Label: DRY SCALP CARE- pyrithione zinc shampoo
- NDC Code(s): 37808-296-15, 37808-296-35
- Packager: HEB
- 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 1, 2022
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- Claims
- Active ingredient
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- use
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- Stop use and ask a doctor if
- Keep out of reach of children
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Inactive ingredients
water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone
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INGREDIENTS AND APPEARANCE
DRY SCALP CARE
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-296 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) sodium laureth sulfate (UNII: BPV390UAP0) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CARBONATE (UNII: EQR32Y7H0M) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALMOND OIL (UNII: 66YXD4DKO9) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-296-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2009 2 NDC:37808-296-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/15/2009 Labeler - HEB (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37808-296) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37808-296)