Label: MOISTURIZING DANDRUFF 1% PYRITHIONE ZINC- pyrithione zinc shampoo
- NDC Code(s): 54111-169-50
- Packager: Bentley Laboratories, LLC
- 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 April 6, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
INGREDIENTS: WATER/AQUA/EAU, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL HYDROXYSULTAINE, ACRYLATES COPOLYMER, FRANGRANCE/PARFUM, PROPANEDIOL, PANTHENOL, SALICYLIC ACID, POLYQUATERNIUM-53, PHENOXYETHANOL, COCAMIDOPROPYLAMINE OXIDE, POLYQUATERNIUM-6, CAPRYLYL GLYCOL, SODIUM BENZOATE, PEG-120 METHYL GLUCOSE DIOLEATE, RAPHANUS SATIVUS (RADISH) ROOT EXTRACT, PROPYLENE GLYCOL, SODIUM HYDROXIDE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, SODIUM POLYNAPHTHALENESULFONATE, SODIUM CHLORIDE, XANTHAN GUM, HYDROXYCITRONELLAL, AMYL CINNAMAL
- Geologie Package
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INGREDIENTS AND APPEARANCE
MOISTURIZING DANDRUFF 1% PYRITHIONE ZINC
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1.0 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) LUVISET 360 (UNII: 05BG6GY6YK) PROPANEDIOL (UNII: 5965N8W85T) PANTHENOL (UNII: WV9CM0O67Z) SALICYLIC ACID (UNII: O414PZ4LPZ) POLYQUATERNIUM-53 (UNII: FLN8G45C73) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM BENZOATE (UNII: OJ245FE5EU) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) RADISH (UNII: EM5RP35463) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SODIUM METHYLENEBISNAPHTHALENESULFONATE (UNII: YD6DS3JR98) SODIUM CHLORIDE (UNII: 451W47IQ8X) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-169-50 236 mL in 1 POUCH; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 03/01/2023 Labeler - Bentley Laboratories, LLC (068351753) Registrant - Geologie (081158549)