Label: EXTRA STRENGTH ITCH STOPPING- itch stopping cream cream
- NDC Code(s): 52000-071-01, 52000-071-02
- Packager: Universal Distribution Centre LLC
- 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 February 21, 2022
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- SPL UNCLASSIFIED SECTION
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ITCH STOPPING
itch stopping cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-071 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) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-071-02 1 in 1 CARTON 01/21/2021 1 NDC:52000-071-01 35.4 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 01/21/2021 Labeler - Universal Distribution Centre LLC (019180459) Registrant - Anicare Pharmaceutical Pvt. Ltd. (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceutical Pvt. Ltd. 916837425 manufacture(52000-071)