Label: BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel
- NDC Code(s): 69968-0242-3
- 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 June 30, 2023
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- PRINCIPAL DISPLAY PANEL - 103 mL Tube Label
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INGREDIENTS AND APPEARANCE
BENADRYL EXTRA STRENGTH ITCH STOPPING
diphenhydramine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0242 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 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0242-3 103 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2013 Labeler - Johnson & Johnson Consumer Inc. (118772437)