Aluminum Zirconium Tetrachlorohydrex Gly 20%

Purpose

Antiperspirant

Warnings:

For external use only.

Do not use on broken skin

Ask a doctor before use if you have kidney disease

Stop use if rash or irriation occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

CYCLOPENTASILOXANE, TRIBEHENIN, DIMETHICONE, PETROLATUM, TRISILOXANE, C18-36 ACID TRIGLYCERIDE, AQUA ((WATER) EAU), PARFUM (FRAGRANCE), SODIUM STARCH OCTENYLSUCCINATE, SILICA DIMETHICONE SILYLATE, ISOPROPYL MYRISTATE, ETHYLENE BRASSYLATE, BENZYL ALCOHOL, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF EXTRACT, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL, CITRONELLOL, ALPHA-ISOMETHYL IONONE, MANNITOL, SILICA, GERANIOL, BHT, SODIUM ASCORBATE, CITRIC ACID, CALCIUM DISODIUM EDTA

Reduces underarm wetness

Revlon Mitchum Clinical Strength Soft Solid

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-624
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10967-624-24	70 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
2	NDC:10967-624-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
3	NDC:10967-624-50	14 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-626
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10967-626-24	70 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
2	NDC:10967-626-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
3	NDC:10967-626-50	14 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-627
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10967-627-24	70 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
2	NDC:10967-627-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
3	NDC:10967-627-50	14 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-646
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10967-646-24	70 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
2	NDC:10967-646-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014
3	NDC:10967-646-50	14 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-625
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10967-625-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-641
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	0.2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
SODIUM ASCORBATE (UNII: S033EH8359)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
TRISILOXANE (UNII: 9G1ZW13R0G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10967-641-16	47 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	01/01/2014

Labeler - Revlon Consumer Products Corp (788820165)

Name	Address	ID/FEI	Business Operations
Establishment
DMI		076693183	manufacture(10967-624, 10967-626, 10967-627, 10967-646, 10967-625, 10967-641)