Label: LEADER ANTI ITCH- diphenhydramine hydrochloride, zinc acetate cream
- NDC Code(s): 70000-0388-1
- Packager: Cardinal Health 110, LLC. dba Leader
- 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 March 24, 2022
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- Active ingredients
- 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
LEADER ANTI ITCH
diphenhydramine hydrochloride, zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0388 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 CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) PEG-2 STEARATE (UNII: 94YQ11Y95F) PEG-20 STEARATE (UNII: NBX892EA57) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0388-1 1 in 1 CARTON 12/13/2018 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 12/13/2018 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)