Label: WINCO ORIGINAL STRENGTH ANTI-ITCH- diphenhydramine hydrochloride, and zinc acetate cream
- NDC Code(s): 67091-277-28
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 31, 2022
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ACTIVE INGREDIENT
Active ingredients.............................................................................Purposes
Diphenhydramine HCl 1%...................................................... Topical analgesic
Zinc acetate 0.1%...................................................................... Skin protectant
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WINCO ORIGINAL STRENGTH ANTI-ITCH
diphenhydramine hydrochloride, and zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-277 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 10 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-277-28 1 in 1 CARTON 02/09/2015 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/09/2014 Labeler - WinCo Foods, LLC (056098817)