Label: FLAKES CEDAR MINT ANTI DANDRUFF- pyrithione zinc lotion/shampoo
- NDC Code(s): 52261-1400-1
- Packager: Cosco International, Inc.
- 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 December 1, 2022
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- Official Label (Printer Friendly)
- DRUG FACTS
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:
WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID - QUESTIONS
- STORAGE AND HANDLING
- 266ml NDC: 52261-1400-1
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INGREDIENTS AND APPEARANCE
FLAKES CEDAR MINT ANTI DANDRUFF
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-1400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.02 kg in 1 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) PEPPERMINT OIL (UNII: AV092KU4JH) TEA TREE OIL (UNII: VIF565UC2G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-1400-1 0.266 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/01/2022 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-1400) , label(52261-1400) , pack(52261-1400)