Label: BANOPHEN- diphenhydramine hydrochloride, zinc acetate cream
- NDC Code(s): 0904-5354-31
- Packager: Major Pharmaceuticals
- 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 July 28, 2020
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- •
- on large areas of the body
- •
- with any other product containing diphenhydramine, even one taken by mouth
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hydrochloride, zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5354 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PEG-2 STEARATE (UNII: 94YQ11Y95F) PEG-20 STEARATE (UNII: NBX892EA57) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5354-31 1 in 1 CARTON 06/19/2009 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 06/19/2009 Labeler - Major Pharmaceuticals (191427277)