Label: REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID- aluminum zirconium tetrachlorohydrex gly liquid
REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID- aluminum zirconium tetrachlorohydrex gly liquid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-624-16, 10967-624-24, 10967-624-50, 10967-625-16, view more10967-626-16, 10967-626-24, 10967-626-50, 10967-627-16, 10967-627-24, 10967-627-50, 10967-641-16, 10967-646-16, 10967-646-24, 10967-646-50 - Packager: Revlon Consumer Products Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 9, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- WARNINGS
- Keep Out of Reach of Children
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INACTIVE INGREDIENT
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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-626 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-627 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-646 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-625 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-625-16 47 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID
aluminum zirconium tetrachlorohydrex gly liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-641 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 0.2 g in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-641-16 47 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 Labeler - Revlon Consumer Products Corp (788820165) Establishment Name Address ID/FEI Business Operations DMI 076693183 manufacture(10967-624, 10967-626, 10967-627, 10967-646, 10967-625, 10967-641)