NDC Code(s) : 10967-650-25
Packager : Revlon Consumer Products Corp

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

American CrewPyrithione Zinc SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-650
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC(UNII: R953O2RHZ5)
(PYRITHIONE ZINC - UNII:R953O2RHZ5) 		PYRITHIONE ZINC1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
MENTHOL(UNII: L7T10EIP3A)
WATER(UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE(UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
DI-PPG-2 MYRETH-10 ADIPATE(UNII: 4IN301M0KJ)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)(UNII: JZ1374NL9E)
CITRIC ACID(UNII: 2968PHW8QP)
HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE(UNII: MVW5LK6LFT)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
PANTHENOL(UNII: WV9CM0O67Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10967-650-25250 mL in 1 CONTAINER Type 0: Not a Combination Product01/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 01/01/2013

LABELER - Revlon Consumer Products Corp(788820165)

Establishment
Name Address ID/FEI Business Operations
REVLON, INC. 809725570 manufacture(10967-650)

PRINCIPAL DISPLAY PANEL

American Crew 2-In-1 Anti-Dandruff & Sebum Control Shampoo

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