Label: BIOTIN H3 ANTI-DANDRUFF NORMAL- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 73388-102-12 - Packager: Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable
- 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 January 14, 2021
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Inactive Ingredient
Water, Sodium Laureth Sulfate, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Dimethiconol (and) TEA-Dodecylbenzenesulfonate, Glycerin, Tetrasodium EDTA, DMDM Hydantoin (and) Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid, PEG-120 Methyl Glucose Dioleate, Fragrance, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Polyquaternium -7
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INGREDIENTS AND APPEARANCE
BIOTIN H3 ANTI-DANDRUFF NORMAL
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73388-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) COCO MONOETHANOLAMIDE (UNII: C80684146D) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DMDM HYDANTOIN (UNII: BYR0546TOW) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) EDETATE SODIUM (UNII: MP1J8420LU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73388-102-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/09/2019 Labeler - Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable (851242271)
