Label: SELECT BRAND EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 15127-055-04 - Packager: Select Brand
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated January 8, 2015
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INGREDIENTS AND APPEARANCE
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diphenhydramine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-055 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 10 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-055-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/11/2012 Labeler - Select Brand (043562370) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(15127-055)