Label: HEAD AND SHOULDERS GROOMING- pyrithione zinc paste
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Contains inactivated NDC Code(s)
NDC Code(s): 69423-480-85 - Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 21, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, ceresin, cetearyl alcohol, petrolatum, cetyl alcohol, copernicia cerifera (carnauba) wax, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, ceteareth-25, PVP, dicaprylyl maleate, mineral oil, aminomethyl propanol, carbomer, benzyl alcohol, 1,2-hexanediol, caprylyl glycol, fragrance, panthenol, niacinamide, caramel.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Jar Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS GROOMING
pyrithione zinc pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-480 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) CARNAUBA WAX (UNII: R12CBM0EIZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MINERAL OIL (UNII: T5L8T28FGP) DIOCTYL MALEATE (UNII: OD88G8439L) BENZYL ALCOHOL (UNII: LKG8494WBH) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PANTHENOL (UNII: WV9CM0O67Z) CETEARETH-25 (UNII: 8FA93U5T67) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) POVIDONE K12 (UNII: 333AG72FWJ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PETROLATUM (UNII: 4T6H12BN9U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CARAMEL (UNII: T9D99G2B1R) CERESIN (UNII: Q1LS2UJO3A) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-480-85 85 g in 1 JAR; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/01/2020 Labeler - The Procter & Gamble Manufacturing Company (004238200)