AMERICAN CREW- pyrithione zinc shampoo

American Crew by

Drug Labeling and Warnings

American Crew by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

DOSAGE & ADMINISTRATION

Keep out of Reach of Children

Label

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

INGREDIENTS AND APPEARANCE

AMERICAN CREW 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-650-25	250 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2013

Labeler - Revlon Consumer Products Corp (788820165)

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