Label: SAFEWAY DANDRUFF- pyrithione zinc liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 21130-415-14 - Packager: SAFEWAY 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 16, 2011
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- ACTIVE INGREDIENT
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- DIRECTIONS
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INACTIVE INGREDIENTS:
WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, FRAGRANCE (PARFUM), CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM XYLENE SULFONATE, BLUE 1 (CI 42090), RED 4 (CI 14700), YELLOW 10 (CI 47005).
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INGREDIENTS AND APPEARANCE
SAFEWAY DANDRUFF
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO MONOETHANOLAMIDE (UNII: C80684146D) ZINC CARBONATE (UNII: EQR32Y7H0M) GLYCOL DISTEARATE (UNII: 13W7MDN21W) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-415-14 420 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/03/2012 Labeler - SAFEWAY INC. (009137209) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture