Label: SAVVY ITCH STOPPING- diphenhydramine hydrochloride zinc acetate cream
- NDC Code(s): 83650-102-01
- Packager: Savvy Care and Cosmetics
- 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 September 22, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
SAVVY ITCH STOPPING
diphenhydramine hydrochloride zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83650-102 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 CATION 0.1 g in 100 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83650-102-01 35.4 g in 1 TUBE; Type 0: Not a Combination Product 09/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/22/2023 Labeler - Savvy Care and Cosmetics (915039748) Establishment Name Address ID/FEI Business Operations Savvy Care and Cosmetics 915039748 manufacture(83650-102)