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PREOPERATIVE CARE

Simple Interventions. Extraordinary Outcomes.

Sage® 2% Chlorhexidine Gluconate Prep Clothsand Nose To Toes™ System

Early skin prep—night before and morning of all surgeries

SSI RISK FACTORS6PATIENT:

n Age

n Nutritional status

n Diabetes

n Nicotine use

n Obesity

n Coexistent infection at remote site

n Colonization with microorganisms

HOSPITAL:n Inappropriate use of antibiotic prophylaxis

n Infection at remote site not treated before surgery

n Shaving vs. clipping

n Improper skin preparation

THE #1 SOURCE OF SURGICAL SITE INFECTION:PATIENTS’ FLORAThe CDC implicates eight pathogens that cause 80% of

healthcare-acquired infections (HAIs).1 Endogenous flora can lead

to surgical site infection (SSI) - one of the most common HAIs.2 In

fact, the #1 cause of SSIs is Staphylococcus aureus, which can be

found in bacterial reservoirs all over the body, including the skin,

nose, and oral cavity.1,3

NOSEThe nose is a common site for S. aureus colonization and

accounts for 80% of all S. aureus infections.3

ORAL CAVITY

Bacteria, including dental plaque, can colonize in the

oropharyngeal area,4 and these pathogens can be aspirated into

the lungs, causing infection.5

SKINThe skin is a major reservoir for bacteria, including methicillin-

resistant S. aureus (MRSA), vancomycin-resistant enterococci (VRE)

and Acinetobacter.

1 www.sageproducts.com

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THE #1 THREAT TO SURGICAL PATIENTS:SURGICAL SITE INFECTION Surgical site infections (SSIs) are the second most common

healthcare-acquired infection2 and one of the most costly.2

Approximately 60 million inpatient and ambulatory surgical

procedures are performed in the U.S. every year.7,8 Of those,

surgical site infections (SSIs) occur after 2.6% to 5% of them.7,9

That amounts to 1.5 million SSIs annually.10 SSIs can also add

7-10 days to a patient's length of stay2 and significantly

increase costs8 and mortality risk.11

n Obesity

n Coexistent infection at remote site

n Colonization with microorganisms

REFERENCES: 1. CDC 2012 Year in Review. Infection Control Today. 2 Scott, D. The Direct Medical Costs of Healthcare-Associated Infection in US Hospitals and the Benefits of Prevention. Division of Healthcare Quality Promotion National Center for Preparedness, Detection, and Control of InfectiousDiseases Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention March 2009. 3. Wertheim HFL, The Lancet 2004. Hidron AL, Infection Control and Hospital Epidemiology 2008. 4. Scannapieco FA, J Peridontology. 1999 Jul; 70(7):793-802. 5. Fourrier F, et al., Crit Care Med.1998;26: 301-8. 6. Mangram AJ, et al., Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital Infection Control Practices Advisory Committee, Atlanta GA. 7. DeFrances CJ, Hall MJ, Podgornik MN, 2003 National hospital discharge survey. CDC, NationalCenter for Health Statistics, Advance Data from Vital and Health Statistics. No. 359;8 July 2005:14. 8. Hall MJ, Lawrence L, Ambulatory surgery in the United States, 1996. CDC, National Center for Health Statistics, Advance Data from Vital and Health Statistics. No. 300;12Aug1998:7. 9. Stone PW, et al., AmJ Infect Control. Nov 2005;33(9):501-9. 10. Figure calculated by multiplying SSI rate from ref #1 by procedures numbers from ref #3 and #4. 11. Kirkland KB, et al., Infect Control Hosp Epidemiol. Nov 1999;20(11):722-4. 12. Federal Register, Vol. 72 No.162, 2007 Aug: 47201-47205. 13. McGarry SA et al.,Infect Control Hosp Epidemiol; June 2004; 25(6): 461-7. 14. Engermann JJ, et al., Clin Infect Dis. 1 Mar 2003;36(5);592-8.

HUMAN COST:11

n Twice as likely to die

n 60% more likely to spend time in an ICU

n Over 5 times more likely to be readmitted

A study of elderly patients found SSI due to S. aureus was responsible for more thana 5-fold increase in mortality13 and anotherstudy shows MRSA in a surgical wound resultedin over a 12-fold increase in mortality.14

5xmortality

SSIS + READMISSION: A COSTLY PROBLEMFINANCIAL COSTS:

n SSIs are the #1 most costly healthcare-acquired infection (HAI),costing hospitals more than $7 billion a year.2

n Each SSI can increase costs by an average of $25,546.9 That risesto more than $90,000 for MRSA infection.9

n The Centers for Medicare and Medicaid Services (CMS) no longerreimburses hospitals for certain SSIs, including mediastinitis.12


EARLY ANTISEPTIC PREP STRATEGIES HELPREDUCE SSI RISK

The Prep Check label is an easy-to-use tool to helpverify a patient’s skin has been prepped accordingto your facility’s protocol. Prep Check helps notifystaff that a patient’s skin has been prepped.

Our free customizable template can help youimplement skin prep verification at your facility.

Download at:www.sageproducts.com/education/preoperative-care/chgTemplate.asp

MORNING OF SURGERYOnce patients arrive at the hospital, it is important to continue

early prepping by addressing the three main reservoirs of

bacteria—nose, oral cavity, and skin—before the patient enters

the OR. Sage’s Nose to ToesTM kit helps you address these

reservoirs before surgery to reduce the risk of SSI.

One study was able to achieve a rate of zero SSIs by implementing

a comprehensive checklist including a nasal antiseptic applied

intranasally in the preoperative area and using Sage 2% CHG

Prep Cloths the night before and morning of surgery.3

NIGHT BEFORE SURGERYEarly prepping can begin at the patient’s home. Sage® 2% CHG

Prep Cloths are easy to use, which may improve compliance to

Pre-Admission Testing (PAT) recommendations.

In a recent study, chin-to-toe application of Sage’s 2% CHG Prep

Cloths the night before and morning of surgery led to a 70%

reduction in SSIs.1 Another study published in the Journal of Knee

Surgery achieved a 72% reduction in SSIs with application of Sage’s

2% CHG Prep Cloths the night before and morning of surgery.2

AT HOME

Scan this QR codewith your smartphonefor direct access

COMPLIANCE

PRE-ADMISSION TESTING

IN HOSPITAL

PRE-OP HOLDING

The Informed Patient:How hospitals are trying to prevent

post-surgery infections

As seen inTHE WALL STREET JOURNAL

www.sageproducts.com/education/preoperative-care

Click here for template

http://www.sageproducts.com/education/preoperative-care/chgTemplate.asp

http://www.sageproducts.com/education/preoperative-care/

4800-323-2220

CDC RECOMMENDATIONS FOR PREVENTION OFSURGICAL SITE INFECTION6

7. Require patients to shower or bathe with an antiseptic agenton at least the night before the operative day. Category IB†

† Category IB - Strongly recommended for implementation and supported by someexperimental, clinical, or epidemiological studies and strong theoretical rationale.

SHEA COMPENDIUM OF STRATEGIES TO PREVENTHEALTHCARE-ASSOCIATED INFECTION IN ACUTECARE HOSPITALS7

“To gain maximum antiseptic effect of chlorhexidine, it must be allowed to dry completely and not be washed off.”

ANNALS OF SURGERY8

“Additional use of a cloth impregnated with chlorhexidine ismore effective than simple showering.”

AORN GUIDELINES FOR PREOPERATIVE SKIN ANTISEPSIS9

“Patients undergoing open class I surgical procedures below the chin should have two (2) preoperative showers with chlorhexidine gluconate (CHG) before surgery, whenappropriate.”

APIC GUIDE TO THE ELIMINATION OFORTHOPEDIC SSI10

“A rinse-free CHG Cloth has been introduced as an alternativeto CHG showers, and some data suggest ease of use andimproved patient compliance as well as reduced rates of SSI.”

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PROFESSIONALLY ACCEPTEDThe use of Sage 2% CHG Prep Cloths as part of a surgical siteinfection prevention program is being cited by professionalorganizations across the healthcare industry.

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COST EFFECTIVE TODISPENSE FOR HOME-BASED PREPPINGA recent study published in Infection Control and

Hospital Epidemiology (ICHE) titled “Economic Value of

Dispensing Home-Based Preoperative Chlorhexidine

Bathing Cloths to Prevent Surgical Site Infection” found

Sage 2% CHG Prep Cloth to be extremely cost-effective

for routine distribution. The study goes on to say “…this

intervention remains cost-effective over a wide range of

cloth efficacy and patient compliance values.”4

COST EFFECTIVE FOR SSI PREVENTIONA clinical poster presented at IHI showed one facility

realized a cost avoidance of $349,000 over a 10-month

period using Sage 2% CHG Prep Cloths.5 SEE GRAPH BELOW

$100K

0

$200K

$300K

$400K

$500K

$600K

$700K

Tota

l cos

t of S

SIs /

10 m

onth

s

Cost comparison 10 months pre- and 10 months post-intervention

Total ROI** Savings = $348,923

11 SSIs

25 SSIs

Pre- and Post-Intervention Cost of SSIs*

Pre-intervention Post-intervention

* Based on average cost/SSI = $25,5465 ** ROI = Return-On-Investment

Investment-Product CostSSI Cost

REFERENCES: 1. Kapadia BH, et al., Pre-admission cutaneous chlorhexiding preparation reduces surgical site infections in total hip arthroplasty. JArthroplasty, 2012. 2. Johnson AJ, et al., Chlorhexidine reduces infections in knew arthroplasty. J Knee Surgery, 2012. 3. Hogenmiller, Jette R., et al.,Preventing orthopedic total joint replacement surgerical site infections through a comprehensive best practice bundle/checklist. Poster presented atAssociation for Professionals in Infection Control and Epidemiology (APIC) June 2011. 4. Bailey R, et al., Economic Value of Dispensing Home-BasedPreoperative Chlorhexidine Bathing Cloths to Prevent Surgical Site Infection. Infetion Control and Hospital Epidemiology. 32(5)456-471. 5. Eiselt D,Presurgical Skin Preparation with a Novel 2% Chlorhexidine Gluconate (CHG) Cloth Leads toDecrease in Surgical Site Infection Rates in OrthopedicSurgical Patients. Poster presented at Association for Professionals in Infection Control and Epidemiology (APIC) June 2007. 6. Mangram AJ, et al.,Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital Infection Control Practices AdvisoryCommittee, Atlanta GA. 7. Society for Healthcare Epidemiology of America, Oct 2008, Vol 29, Supplement 1, S58. 8. Alexander JW, et al., Updatedrecommendations for control of surgical site infections. Annals of Surgery. 2011;253(6):1082-1093. 9. Perioperative Standards and RecommendedPractices, Association of periOperative Registered Nurses (AORN), 2008, 537-555. 10. Guide to Elimination of Orthopedic Surgical Site Infections.Association for Professionals in Infection Control and Epidemiology (APIC), 2010.


THE FIRST FDA-APPROVEDPREOPERATIVE SKIN PREP IN A CLOTHSage 2% CHG Prep Cloths address multidrug resistant organisms

(MDROs) on the patients’ skin – a known risk factor for SSIs.1 Sage’s

innovative rinse-free, alcohol-free formula is

designed for early preop prep. It stays on the

skin for up to 6 hours of maximum

persistence after application. The cloth

consistently delivers a uniform dose of CHG,

unlike other soaps and solutions.

2% FORMULA PROVEN EFFECTIVEn Effective against broad spectrum of MDROs, including MRSA, VRE and Acinetobacter.2,3

n Recognized by CDC as having “excellent” activity against gram-positive bacteria as well as “excellent” residual activity.1

3.80

2.60

2.80

3.00

3.20

3.40

3.60

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Baseline = 6.15 log10

10 minutes 30 minutes 6 hours

3.80

2.60

2.80

3.00

3.20

3.40

3.60

Log

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ion fro

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2.20

2.30

2.40

2.50

2.60

2.70

2.80

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2.20

2.30

2.40

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2.60

2.70

2.80

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educt

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>2Log10 Reduction3.80

2.60

2.80

3.00

3.20

3.40

3.60

Log 1

0 Red

uctio

n fro

m B

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2.60

2.80

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3.20

3.40

3.60

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educt

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m B

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2.20

2.30

2.40

2.50

2.60

2.70

2.80

Log 1

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2.40

2.50

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2.80

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>3Log10 Reduction

Sage 2% CHG Prep Cloths to the Abdominal Site2 Sage 2% CHG Prep Cloths to the Inguinal Site2

6 hoursof persistence

“The 2% CHG-impregnated clothappears to be apractical and effectiveproduct for inpatientand outpatientsettings.”7

SAGE® 2% CHLORHEXIDINEGLUCONATE (CHG) PREP CLOTHS

Staphylococcus aureus(including MRSA) 4

Enterococcus faecalis & faecium (including VRE) 4

Coagulase-negative staphylococci 4

Streptococcus pneumoniae & pyogenes 4

Various other gram-positive aerobes 4

Acinetobacter baumannii 4

Bacteroides fragilis 4

Enterobacter aerogenes 4

Escherichia coli 4

Klebsiella pneumoniae 4

Proteus mirabilis 4

Pseudomonas aeruginosa 4

Serratia marcescens 4

Candida albicans 4

SAGE 2% CHG PREP CLOTH

EFFECTIVE AGAINST PREVALENT SSI-CAUSINGPATHOGENS2,*

6800-323-2220

REFERENCES: 1. Mangram AJ, et al., Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention,Hospital Infection Control Practices Advisory Committee, Atlanta GA. 2. Time Kill and MIC Testing conducted by an independent laboratory; dataon file. 3. Testing conducted by an independent laboratory; data on file. 4. Edmiston CE, et al., Comparative of a new and innovative 2%chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery.American Journal of Infection Control(AJIC). Mar 2007;35(2):89-96. 5. Ryder M, Improving Skin Antisepsis: 2% No-Rinse CHG Cloths ImproveAntiseptic Persistence on Patient Skin Over 4% CHG Rinse-Off Solution. Poster presented at Association for Professionals in Infection Control andEpidemiology (APIC) June 2007. 6. Guide to Elimination of Orthopedic Surgical Site Infections. Association for Professionals in Infection Controland Epidemiology (APIC), 2010. 7. Society for Healthcare Epidemiology of America, Oct 2008, Vol 29, Supplement 1, S58.

Average Residual CHGby Sample Area

4% rinse-off CHG solution 2% no-rinse CHG cloths

Right arm Left arm Abdomen Left leg Right leg

45

40

35

30

25

20

15

10

5

0

Aver

age

CHG

(ug)

A study published in the American Journalof Infection Control found that 2%CHG impregnated cloths left moreCHG on the skin than 4% CHGantisepetic soap.4

Another study found the amount ofCHG that remains on the skin afterapplication of no-rinse 2% CHG PrepCloths is significantly higher than a 4% CHGthat is rinsed off.5 SEE GRAPH BELOW

* In vitro testing.

5

GRAM-POSITIVE PATHOGEN

GRAM-NEGATIVE PATHOGEN

FUNGI

APIC:“A rinse-free CHG Cloth has been introduced as an alternativeto CHG showers, and some data suggest ease of use and improvedpatient compliance as well as reduced rates of SSI.” 6

NO MORE RINSING CHGSOLUTION DOWN THE DRAIN!

SHEA:“To gain maximum antiseptic effect of chlorhexidine, it mustbe allowed to dry completely and not be washed off.” 7

VS.

4% CHG soap

NO-RINSE 2% CHG PREP CLOTHLEAVES MORE CHG ON SKINTHAN 4% SOAP

GUIDELINE SUPPORT FOR RINSE-FREE CHG

2% CHG impregnated cloths

ADDRESS BACTERIA OF 3 RESERVOIRS:NARES, ORAL CAVITY AND SKINThe Nose to Toes™ early prepping system helps address infectionrisk factors on three main reservoirs of bacteria: the nares, the oralcavity, and the skin.

3

N A S A L P R E P P I N G

3MTM Skin And Nasal Antiseptic(Povidone-Iodine Solution 5% w/w [0.5% available iodine]USP) Patient Preoperative Skin Preparation

Single dose bottle of 3MTM PeridexTM (ChlorhexidineGluconate 0.12%) Oral Rinse and Ultra-SoftToothbrush helps remove dental plaque andprovides antimicrobial activity during oral rinsing.

Sage 2% CHG Prep Cloths contain a rinse-freesolution for effective skin antisepsis. Persistenceand cumulative effect with multiple applications.

Sage® 2% Chlorhexidine Gluconate (CHG)Patient Preoperative Skin Preparation Cloths

Sage® Oral Care Products with 3M™ Peridex™

0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

3MTM Skin and Nasal Antiseptic reduces bacterialcounts in the nares in one hour, and maintains thisreduction for at least 12 hours.1

O R A L C L E A N S I N G

S K I N P R E P P I N G3

See label on back of catalog

SAGE® NOSE TO TOES PRE-OP PREPPING SYSTEM

3Mand Peridex are trademarks of 3M


REFERENCES: 1. 3M Study-05-011100

The clinical significance of Peridex oral rinse’s antimicrobial activity is not clear. Three months after Peridex oral rinse was discontinued, the number of bacteria in plaque had returned to baseline levelsand resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline. Clinical effectiveness and safety of Peridex oral rinse has not been established in children under age 18.

Peridex oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis. Patients with a known sensitivity to chlorhexidine gluconate should not usePeridex oral rinse. The effect of Peridex oral rinse on periodontitis has not been determined. Common side effects associated with the use of Peridex oral rinse include an increase in the staining of oralsurfaces, an increase in calculus formation, and an alteration in taste perception. For additional information, please see the full prescribing information.

2

1

Based on unique features and functionality properly matchedto target market needs, along with brand perception of theuniqueness of Nose To Toes™, Sage Products has been chosenas the worthiest recipient of the 2012 Frost & Sullivan GlobalProduct Differentiation Excellence Award.

Sage Products Receives Frost & SullivanProduct Differentiation Excellence Award Patient Prepping Nose to ToesTM | Global, 2012

SAGE® INNOVATION

8800-323-2220

21


FDA approved 2% CHG formula

n Persistent, rinse-free formula stays active for 6 hours after application.

n Proven to reduce drug-resistant MRSA and Acinetobacterby 99.9%.1

n Cleans and moisturizes with surfactants and humectants.n Fast-acting, broad-spectrum and alcohol-free—which reduces flammability risk and won’t dry out skin.

n Active in the presence of blood and other organic matter.

FDA approved applicator cloth

n Delivers a uniform dose (500mg of CHG in each cloth)of CHG to the skin.

n Easier for patient with impaired mobility.n Replaces bottled solutions rinsed off in shower.n Nonabrasive, textured cloth removes debris, allowing CHG to thoroughly cover prep area.

n No drips, runs or pooling.

Prep Check™ label

n Peel-and-stick label helps notify staff that a patient’s skin has been prepped to improve communication.

n Helps improve skin prep compliance by improvingcommunication between caregiver and patient.

n Enhances documentation procedures.

Our skin-friendly Prep Cloths are easy to use and delivera uniform dose of CHG to the skin. Fast-acting, broad-spectrum and alcohol-free, our 2% CHG stays on theskin to help prevent infection.

REFERENCES: 1. DeBaun B, New Alcohol-Free 2% CHG Solution Reduced Bacterial Counts of Drug-Resistant Acinetobacter and MRSA by 99.9%. Poster presented at the 2007 Association of periOperative Registered Nurses (AORN) Congress, Orlando, FL Mar 2007.

* In vitro testing.

SAGE® 2%CHLORHEXIDINE GLUCONATE CLOTHS*

2 cloths per packagecloth size: 7.5” x 7.5”

96 packages/caseReorder #9705

2 cloths per packagecloth size: 7.5” x 7.5


SAGE® 2%CHLORHEXIDINE GLUCONATE CLOTHS*

3 individually wrapped packages (2 cloths per package); cloth size: 7.5” x 7.5”


PRODUCT ORDERING:

NIGHT BEFORE SURGERY

Our free customizable template can help you implement skin prep verification at your facility.

Download at:www.sageproducts.com/education/preoperative-care/chgTemplate.asp Use your smartphone

to scan for direct access

*Equivalent to 500mg chlorhexidine gluconate per cloth

SAGE® 2% CHG PREP CLOTHSAddress multi-drug resistant organisms on your

patient’s skin prior to surgery

Click here for template

http://www.sageproducts.com/education/preoperative-care/chgTemplate.asp

10800-323-2220

PRODUCT ORDERING:

3 Packages containing: 2 Cloths Sage® 2% ChlorhexidineGluconate* Patient PreoperativeSkin Preparation

1 Package containing:1 Single dose bottle of 3M™

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse

1 Ultra-Soft Toothbrush 1 Untreated Swab

1 Package containing:1 Single dose bottle of 3M™ Skinand Nasal Antiseptic (Povidone-Iodine Solution 5% w/w (0.5%available iodine) USP) PatientPreoperative Skin Preparation

4 Sterile Swabs

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS

20 systems/caseReorder #9011


1 Package containing:1 Single dose bottle of 3M™

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse

1 Ultra-Soft Toothbrush 1 Untreated Swab

SKIN ANTISEPSIS AND ORAL CLEANSING


*Equivalent to 500mg chlorhexidine gluconate per cloth


1 Package containing:1 Single dose bottle of 3M™ Skinand Nasal Antiseptic (Povidone-Iodine Solution 5% w/w (0.5%available iodine) USP) PatientPreoperative Skin Preparation

4 Sterile Swabs

SKIN ANTISEPSIS AND NASAL ANTISEPSIS


Your patient’s bacterial flora is the #1 risk factorfor SSI. Help address infection risk factors on threemain reservoirs of bacteria: the nares, the oralcav ity and the skin.

Nasal Antisepsis

n Alcohol-free. n Convenient, single-dose bottle. n Two-minute application fits easily into yourperioperative process.

n Provides 12 hours of persistence against abroad spectrum of bacteria.1

n Antiseptic formulation won’t lead to resistanceor impact antibiotic stewardship.2

n One hour efficacy. Helps reduce bacteria in thenares just one hour after application.1

Oral Cleansing

n Convenient, single-dose bottle.n Effective against gingivitis—a risk factor for other infections.

n Ultra-Soft Toothbrush contains nylon bristles to gently remove plaque, debris and oral secretions.

See label on back of catalog

Skin Antisepsis

n Rinse-free. Stays on skin for maximumpersistence up to 6 hours after application.

n Effective against MRSA, VRE and Acinetobacter.n Fast-acting, broad-spectrum and alcohol-free—which reduces flammability risk and won’t dryout skin.

NOSE TO TOES™ PRE-OP PREPPINGAddress multi-drug resistant organisms on your

patient’s skin, oral cavity and nares prior to surgery

MORNING OF SURGERY

3Mand Peridex are trademarks of 3MREFERENCES: 1. 3M Study-05-011100 2. 3M Study-05-011322

The clinical significance of Peridex oral rinse’s antimicrobial activity is not clear. Three months after Peridex oral rinse was discontinued, the number of bacteria in plaquehad returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline. Clinical effectiveness and safety of Peridex oralrinse has not been established in children under age 18.

Peridex oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis. Patients with a known sensitivity tochlorhexidine gluconate should not use Peridex oral rinse. The effect of Peridex oral rinse on periodontitis has not been determined. Common side effects associated withthe use of Peridex oral rinse include an increase in the staining of oral surfaces, an increase in calculus formation, and an alteration in taste perception. For additionalinformation, please see the full prescribing information.

3909 Three Oaks Road | Cary, Illinois 60013 | www.sageproducts.com | 800-323-222020778F ©2013 Sage Products LLC 3M and Peridex are trademarks of 3M.

SIMPLE INTERVENTIONS.EXTRAORDINARY OUTCOMES.

Sage Products believes that evidence-based interventions lead to improved clinical outcomes. Ourmarket-leading, innovative products solve real problems in the healthcare industry and are backedby proven clinical evidence. They make it easier for nurses to deliver essential patient care, helpingto prevent healthcare-acquired infections and skin breakdown.

ounces of Peridex™ Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.

DOSAGE AND ADMINISTRATION: Peridex™Oral Rinse therapy should be initiated directly following a dental prophylaxis.Patients using Peridex™ Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer thansix months.

Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is15 mL of undiluted Peridex™ Oral Rinse. Patients should be instructed to not rinse with water, or other mouthwashes,brush teeth, or eat immediately after using Peridex™ Oral Rinse. Peridex™ Oral Rinse is not intended for ingestion andshould be expectorated after rinsing.

HOW SUPPLIED: Peridex™ Oral Rinse is supplied as a blue liquid in single dose amber plastic bottles with child-resistantdispensing closures. Store above freezing (32°F or 0ºC).

Rx only.

DIRECTIONS FOR USE: Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime,or use as prescribed.

NOTE: To minimize medicinal taste, do not rinse with water immediately after use.

To open, press down while turning cap. To reseal, turn cap past “clicks” until tightly locked.

WHAT TO EXPECT WHEN USING Peridex™ ORAL RINSEYour dentist has prescribed Peridex™ Oral Rinse to treat your gingivitis, to help reduce the redness, and swelling of yourgums, and also to help you control any gum bleeding. Use Peridex™ Oral Rinse regularly, as directed by your dentist, inaddition to daily brushing. Spit out after use. Peridex™ Oral Rinse should not be swallowed.

Peridex™ Oral Rinse may cause some tooth discoloration, or increase in tartar (calculus) formation, particularly in areaswhere stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every sixmonths or more frequently if your dentist advises.

• Both stain and tartar can be removed by your dentist or hygienist. Peridex™ Oral Rinse may cause permanentdiscoloration of some front-tooth fillings.

• To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.• Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Peridex™Oral Rinse shouldnot be used by persons who have a sensitivity to it or its components.

• Peridex™ Oral Rinse may taste bitter to some patients and can affect how foods and beverages taste. This will becomeless noticeable in most cases with continued use of Peridex™ Oral Rinse.

• To avoid taste interference, rinse with Peridex™ Oral Rinse after meals.

Do not rinse with water or other mouthwashes immediately after rinsing with Peridex™ Oral Rinse.

If you have any questions or comments about Peridex™ Oral Rinse, contact your dentist or pharmacist. STORE ABOVE FREEZING (32°F OR 0°C)

Made in USA for 3M Health Care/ 3M ESPE Dental ProductsSt. Paul, MN 55144-1000(U.S.A.) 1-800-228-3957

Revised: April, 2009©3M 200934-8703-1991-9

2. Peridex™ Oral Rinse can cause staining of oral surfaces, such as tooth surfaces,restorations, and the dorsum of thetongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% ofPeridex™ Oral Rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control usersafter six months; 15% of Peridex™ Oral Rinse users developed what was judged to be heavy stain, compared to 1%of control users after six months. Stain will be more pronounced in patients who have heavier accumulations ofunremoved plaque. Stain resulting from use of Peridex™ Oral Rinse does not adversely affect health of the gingivae orother oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques.Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patientswith anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfacesby a dental prophylaxis, patients should be excluded from Peridex™ Oral Rinse treatment if permanent discoloration isunacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions maynecessitate replacement of these restorations.

3. Some patients may experience an alteration in taste perception while undergoing treatment with Peridex™ Oral Rinse.Rare instances of permanent taste alteration following Peridex™Oral Rinse use have been reported via post-marketingproduct surveillance.

PREGNANCY: TERATOGENIC EFFECTS Pregnancy Category B. Reproduction Studies have been performed in rats andrabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done.Because animal reproduction studies are not always predictive of human response, this drug should be used duringpregnancy only if clearly needed.

NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted inhuman milk, caution should be exercised when Peridex™ Oral Rinse is administered to nursing women.

In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups wasobserved when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than thatwhich would result from a person’s ingesting 30ml of Peridex™ Oral Rinse per day.

PEDIATRIC USE: Clinical effectiveness and safety of Peridex™ Oral Rinse have not been established in children under theage of 18.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY: In a drinking water study in rats, carcinogeniceffects were not observed at doses up to 38mg/kg/day. Mutagenic effects were not observed in two mammalian in vivomutagenesis studies with chlorhexidine gluconate.

The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to100mg/kg/day.

ADVERSE REACTIONS: The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) anincrease in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in tasteperception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneouslyreported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects werereported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration,erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurredat a frequency of less than 1.0%.

Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Peridex™Oral Rinseare stomatitis, gingivitis, glossitis, ulcer, dry mouth, hyperthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Peridex™ Oral Rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patientsusing Peridex™ Oral Rinse.

OVERDOSAGE: Ingestion of 1 or 2 ounces of Peridex™ Oral Rinse by a small child (~10 kg body weight) might result ingastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4

DESCRIPTION: Peridex™ is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitandiisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex™ Oral Rinse is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

CLINICAL PHARMACOLOGY: Peridex™ Oral Rinse provides antimicrobial activity during oral rinsing. The clinicalsignificance of Peridex™ Oral Rinse’s antimicrobial activities is not clear. Microbiological sampling of plaque has shown ageneral reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through sixmonths use.

Use of Peridex™ Oral Rinse in a six month clinical study did not result in any significant changes in bacterial resistance,overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three monthsafter Peridex™ Oral Rinse was discontinued, the number of bacteria in plaque had returned to baseline levels andresistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

PHARMACOKINETICS: Pharmacokinetic studies with Peridex™ Oral Rinse indicate approximately 30% of the activeingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released inthe oral fluids.

Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from thegastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 �g/g in humans 30minutes after they ingested a 300mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present inthe plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconateoccurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjectswas excreted in the urine.

INDICATION: Peridex™ Oral Rinse is indicated for use between dental visits as part of a professional program for thetreatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.Peridex™ Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patientshaving coexisting gingivitis and periodontitis, see PRECAUTIONS.

CONTRAINDICATIONS: Peridex™ Oral Rinse should not be used by persons who are known to be hypersensitive tochlorhexidine gluconate or other formula ingredients.

WARNINGS: The effect of Peridex™ Oral Rinse on periodontitis has not been determined. An increase in supragingivalcalculus was noted in clinical testing in Peridex™Oral Rinse users compared with control users. It is not known if Peridex™Oral Rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxisat intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. SEE CONTRAINDICATIONS.

PRECAUTIONS:GENERAL:1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation followingtreatment with Peridex™ Oral Rinse should not be used as a major indicator of underlying periodontitis.

CHLORHEXIDINE GLUCONATE (0.12%) ORAL RINSE

INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol,glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1.Rx onlyKEEP OUT OF REACH OF CHILDREN0.5 fl oz (15ml)

NDC 48878-0620-4

Call your doctor for medical advice aboutside effects. You may report side effects toFDA at 1-800-FDA-1088.

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