Label: DANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 41190-281-15 - Packager: Wakfern Food Corporation
- 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 June 18, 2012
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, amodimethicone, cocamide MEA, zinc carbonate, glycol distearate,
sodium hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide,
benzyl alcohol, prunus amygdalus dulcis (sweet almond)oil, trideceth-12, cetrimonium chloride, sodium hydroxide,
methylchloroisothiazolinone, methylisothiazolinone - SPL UNCLASSIFIED SECTION
- ADVERSE REACTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-281 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 kg in 100 L Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) ZINC CARBONATE (UNII: EQR32Y7H0M) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR) MAGNESIUM SULFATE (UNII: DE08037SAB) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) ZINC CHLORIDE (UNII: 86Q357L16B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41190-281-15 0.420 L in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/11/1992 Labeler - Wakfern Food Corporation (069722418) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(41190-281)