Label: AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL- pyrithione zinc shampoo
-
Contains inactivated NDC Code(s)
NDC Code(s): 42743-4700-1 - Packager: Colomer USA, Ltd.
- Category: HUMAN OTC DRUG LABEL
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 June 11, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
-
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
-
INGREDIENTS AND APPEARANCE
AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL
pyrithione zinc shampooProduct 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)