Label: BIOKERA- pyrithione zinc lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 59538-001-01 - Packager: SALERM COSMETICA PROFESIONAL, S.A.
- 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 July 2, 2016
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Sodium Laureth Sulfate,
Cocomidopropyl Betane, Acrylates Copolymenr, Frangrance,
Linum Usitatissimum (Linseed) Seed Oil, Salicylic Acid,
Polyquaternum 7, Laureth 4, Glycol Distearate, Cocamide
Mipa, Undecylenamidopropyltrimonium Methosulfate,
Propylene Glycol, Sodium Hydroxide, Sodium Chloride,
Diazolidinyl Urea, Methylsothiazolinine, Iodopropynol
Butylcarbamate, Lactic Acid, Alpha Isomethylionine,
Citronellol
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOKERA
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59538-001 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 g in 10 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CHLOROPROPYLATE (UNII: GI03ROM7HQ) LINSEED OIL (UNII: 84XB4DV00W) HEXYL SALICYLATE (UNII: 8F78EY72YL) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) LAURETH-4 (UNII: 6HQ855798J) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 3-IODO-1-PROPANOL (UNII: 2FR2742AOL) LACTIC ACID (UNII: 33X04XA5AT) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59538-001-01 1 in 1 CARTON 08/01/2013 1 300 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/01/2013 Labeler - SALERM COSMETICA PROFESIONAL, S.A. (563418532)