Label: BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream
- NDC Code(s): 69968-0223-1, 69968-0223-2
- Packager: Johnson & Johnson Consumer Inc.
- 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 January 13, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton
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INGREDIENTS AND APPEARANCE
BENADRYL EXTRA STRENGTH ITCH STOPPING
diphenhydramine hydrochloride and zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0223 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 20 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0223-1 1 in 1 CARTON 11/01/2009 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0223-2 28.3 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2009 Labeler - Johnson & Johnson Consumer Inc. (118772437)