AMERICAN CREW- pyrithione zinc shampoo 
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.

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

Active Ingredients:

Active Ingredients
Pyrithione Zinc 1%

Purpose


Anti Dandruff

Uses:

Controls itching & flaking due to dandruff.

Warnings:

For external use only.
• Avoid contact with eyes. If contact occurs,
rinse eyes thoroughly with water.
• If condition worsens or does not improve
after regular use of this product as directed,
consult a physician.
• Consult a physician prior to use in children
under 2 years of age.
• KEEP OUT OF REACH OF CHILDREN. If
swallowed, get medical help or contact a
Poison Control Center right away.

Directions

• Wet hair thoroughly.
• Massage a small amount of shampoo evenly
into scalp and leave on for a few minutes.
• Rinse well.
• For best results use at least twice a week or
as directed by a physician.

Inactive Ingredients

Aqua (Water) (Eau), Sodium Laureth Sulfate,
Acrylates Copolymer, Cocamidopropyl Betaine,
Glycerin, PEG-12 Dimethicone, Di-PPG-2 Myreth-10
Adipate, Triethanolamine, Hydroxyethylcellulose,
Propylene Glycol, Sodium Chloride,
Polyquaternium-7, Melaleuca
Alternifolia (Tea Tree) Leaf Oil,
Mentha Piperita (Peppermint) Oil,
Rosmarinus Officinalis (Rosemary)
Leaf Extract, Salvia Officinalis
(Sage) Leaf Extract, Sodium
Acetate, Parfum (Fragrance),
Limonene, Phenoxyethanol,
Ethylparaben, Methylparaben

Keep out of Reach of Children

Label

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

label

AMERICAN CREW 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SAGE OIL (UNII: U27K0H1H2O)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-650-25250 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2013
Labeler - Revlon Consumer Products Corp (788820165)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(10967-650)

Revised: 11/2019
Document Id: 9716d8d4-4a20-b376-e053-2a95a90a2b7a
Set id: 9566b567-90be-4803-b940-e6a91750778f
Version: 2
Effective Time: 20191111
 
Revlon Consumer Products Corp