Label: ANTI-DANDRUFF JUNIPER AND EUCALYPTUS- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 71825-105-01 - Packager: Cremo company
- 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 January 15, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-DANDRUFF JUNIPER AND EUCALYPTUS
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71825-105 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 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) GLYCERIN (UNII: PDC6A3C0OX) BENZOIC ACID (UNII: 8SKN0B0MIM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71825-105-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/11/2019 Labeler - Cremo company (078708508) Establishment Name Address ID/FEI Business Operations RNA PHARMA 079103999 manufacture(71825-105)