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Cinnamyl Alcohol, Alpha-Isomethyl Ionone. 24309

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MITCHUM ADVANCE CONTROL- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL SPORT- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL POWDER FRESH- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL PURE FRESH- aluminum chlorohydrate aerosol Revlon Consumer Products Corp Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Revlon Mitchum Aerosol Active Ingredient Aluminum Chlorohydrate 25.0% Directions: Apply to Underarms only Warnings: Do not use on broken skin Stop Use if rash or irritation occurs. When using this product, keep away from face and mouth to avoid breathing in. Avoid spraying in eyes Contents under pressure Do not place in hot water or near radiators, stoves, or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50C Flammable Do not use in presence of flame or spark. Keep out of reach of children Questions? 1-888-864-8248 M-F 7AM-6PM EST Uses Reduces underarm wetness Purpose Anti-Perspirant Inactive Ingredients Hydrofluorocarbon 152a, Cyclopentasiloxane, Butane, C12-15 Alkyl Benzoate, Isopropyl Myristate, Disteardimonium Hectorite, Propylene Carbonate, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Parfum (Fragrance), Linalool, Benzyl Salicylate, Citronellol, Hydroxycitronellal, Hexyl Cinnamal, Limonene, Benzyl Benzoate, Geraniol,
Transcript

MITCHUM ADVANCE CONTROL- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL SPORT- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL POWDER FRESH- aluminum chlorohydrate aerosol MITCHUM ADVANCE CONTROL PURE FRESH- aluminum chlorohydrate aerosol Revlon Consumer Products CorpDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Revlon Mitchum Aerosol

Active IngredientAluminum Chlorohydrate 25.0%

Directions:

Apply to Underarms only

Warnings:

Do not use on broken skin

Stop Use if rash or irritation occurs.

When using this product, keep away from face and mouth to avoid breathing in.

Avoid spraying in eyes

Contents under pressure

Do not place in hot water or near radiators, stoves, or other sources of heat.

Do not puncture or incinerate container or store at temperatures over 50C

Flammable Do not use in presence of flame or spark.

Keep out of reach of children

Questions?

1-888-864-8248 M-F 7AM-6PM EST

UsesReduces underarm wetness

PurposeAnti-Perspirant

Inactive IngredientsHydrofluorocarbon 152a, Cyclopentasiloxane, Butane, C12-15 Alkyl Benzoate, Isopropyl Myristate, Disteardimonium Hectorite, Propylene Carbonate, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Parfum (Fragrance), Linalool, Benzyl Salicylate, Citronellol, Hydroxycitronellal, Hexyl Cinnamal, Limonene, Benzyl Benzoate, Geraniol,

Cinnamyl Alcohol, Alpha-Isomethyl Ionone. 24309

Keep out of Reach of Children

MITCHUM ADVANCE CONTROL

aluminum chlorohydrate aerosol

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 9 6 7-6 35

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -UNII:HPN8 MZW13M)

ALUMINUMCHLOROHYDRATE

0 .25 g in 1 mL

Inactive IngredientsIngredient Name Strength

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

GERANIO L (UNII: L8 3710 8 USY)

CO UMARIN (UNII: A4VZ22K1WT)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

BUTANE (UNII: 6 LV4FOR43R)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

Packaging

# Item Code Package Description Marketing StartDate Marketing End Date

1 NDC:10 9 6 7-6 35-0 4

113.4 mL in 1 CANISTER; Type 0 : No t a Co mbinatio nPro duct 12/0 7/20 15

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part350 12/0 7/20 15

MITCHUM ADVANCE CONTROL SPORT aluminum chlorohydrate aerosol

Product Information

Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 9 6 7-6 36

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -UNII:HPN8 MZW13M)

ALUMINUMCHLOROHYDRATE

0 .25 g in 1 mL

Inactive IngredientsIngredient Name Strength

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

GERANIO L (UNII: L8 3710 8 USY)

CO UMARIN (UNII: A4VZ22K1WT)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

BUTANE (UNII: 6 LV4FOR43R)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

Packaging

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:10 9 6 7-6 36 -0 4

113.4 mL in 1 CANISTER; Type 0 : No t a Co mbinatio nPro duct 12/0 7/20 15

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part350 12/0 7/20 15

MITCHUM ADVANCE CONTROL aluminum chlorohydrate aerosol

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 9 6 7-6 38

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -UNII:HPN8 MZW13M)

ALUMINUMCHLOROHYDRATE

0 .25 g in 1 mL

Inactive IngredientsIngredient Name Strength

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

BUTANE (UNII: 6 LV4FOR43R)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

CO UMARIN (UNII: A4VZ22K1WT)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

Packaging

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:10 9 6 7-6 38 -0 4

113.4 mL in 1 CANISTER; Type 0 : No t a Co mbinatio nPro duct 12/0 7/20 15

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part350 12/0 7/20 15

MITCHUM ADVANCE CONTROL POWDER FRESH aluminum chlorohydrate aerosol

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 9 6 7-6 37

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -UNII:HPN8 MZW13M)

ALUMINUMCHLOROHYDRATE

0 .25 g in 1 mL

Inactive IngredientsIngredient Name Strength

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

BUTANE (UNII: 6 LV4FOR43R)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

GERANIO L (UNII: L8 3710 8 USY)

CO UMARIN (UNII: A4VZ22K1WT)

BENZYL SALICYLATE (UNII: WAO5MNK9 TU)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

Packaging

# Item Code Package Description Marketing StartDate Marketing End Date

1 NDC:10 9 6 7-6 37-0 4

113.4 mL in 1 CANISTER; Type 0 : No t a Co mbinatio nPro duct 12/0 7/20 15

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part350 12/0 7/20 15

MITCHUM ADVANCE CONTROL PURE FRESH aluminum chlorohydrate aerosol

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:10 9 6 7-6 49

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -UNII:HPN8 MZW13M)

ALUMINUMCHLOROHYDRATE

0 .25 g in 1 mL

Revlon Consumer Products Corp

Inactive IngredientsIngredient Name Strength

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

BUTANE (UNII: 6 LV4FOR43R)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

GERANIO L (UNII: L8 3710 8 USY)

CO UMARIN (UNII: A4VZ22K1WT)

BENZYL SALICYLATE (UNII: WAO5MNK9 TU)

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

Packaging

# Item Code Package Description Marketing StartDate

Marketing EndDate

1 NDC:10 9 6 7-6 49 -0 4

113.4 mL in 1 CANISTER; Type 0 : No t a Co mbinatio nPro duct 12/0 7/20 15

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part350 12/0 7/20 15

Labeler - Revlon Consumer Products Corp (788820165)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

American Spraytech 137135237 manufacture(10 9 6 7-6 35, 10 9 6 7-6 36 , 10 9 6 7-6 37, 10 9 6 7-6 38 , 10 9 6 7-6 49 )

Revised: 12/2016


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