Label: ANTIDANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 70549-123-11, 70549-123-22 - Packager: BBCOS S.R.L.
- 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 May 19, 2016
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- Official Label (Printer Friendly)
- Active Ingredient:
- Uses:
- Warnings:
- When using this product:
- Stop using this product and consult a doctor:
- Keep out of reach of children.
- Directions:
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Inactive ingredients:
AQUA (WATER), SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, LAURAMIDOPROPYL BETAINE, PROPYLENE GLYCOL, SODIUM PCA, PEG-7 GLYCERYL COCOATE, PEG-200 HYDROGENATED GLYCERYL PALMATE, PARFUM (FRAGRANCE), BENZYL ALCHOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, TETRASODIUM EDTA, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, MENTHA PIPERITA (MINT) EXTRACT, PEG/PPG-14/4 DIMETHICONE, PIROCTONE OLAMINE, CITRIC ACID, PANTHENOL, MENTHOL
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INGREDIENTS AND APPEARANCE
ANTIDANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70549-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg in 1000 mg Inactive Ingredients Ingredient Name Strength POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1) EDETATE SODIUM (UNII: MP1J8420LU) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) PEG/PPG-14/4 DIMETHICONE (UNII: 646XNV22YX) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) PANTHENOL (UNII: WV9CM0O67Z) MENTHOL (UNII: L7T10EIP3A) SAGE (UNII: 065C5D077J) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) MENTHA PIPERITA (UNII: 79M2M2UDA9) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70549-123-11 1000 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2016 2 NDC:70549-123-22 250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 06/01/2016 Labeler - BBCOS S.R.L. (434126395)