AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL- pyrithione zinc shampoo

American Crew Anti-Dandruff plus Sebum Control by

Drug Labeling and Warnings

American Crew Anti-Dandruff plus Sebum Control by is a Otc medication manufactured, distributed, or labeled by Colomer USA, Ltd., Tri Tech Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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, Methylchloroisothiazolinone, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL - 250mL Bottle Label

AMERICAN
CREW®
TRICHOLOLGY

Official Supplier to Men™

ANTI-DANDRUFF +
SEBUM CONTROL
SHAMPOO

Anti-dandruff + sebum
control shampoo with
conditioning properties

250mL e / 8.4 Fl. Oz.

INGREDIENTS AND APPEARANCE

AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42743-4700
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)
TROLAMINE (UNII: 9O3K93S3TK)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
SODIUM ACETATE (UNII: 4550K0SC9B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42743-4700-1	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	08/31/2013

Labeler - Colomer USA, Ltd. (137750993)

Establishment
Name	Address	ID/FEI	Business Operations
Tri Tech Laboratories		792844680	MANUFACTURE(42743-4700) , PACK(42743-4700)