Label: THE ITCH ERASER- diphenhydramine hydrochloride spray
- NDC Code(s): 90107-2410-1
- Packager: Adventure Ready Brands
- 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 January 19, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients:
- Purpose:
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- Package Labeling
-
INGREDIENTS AND APPEARANCE
THE ITCH ERASER
diphenhydramine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90107-2410 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 OAT (UNII: Z6J799EAJK) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) POVIDONE (UNII: FZ989GH94E) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TEA TREE OIL (UNII: VIF565UC2G) ZINC ACETATE (UNII: FM5526K07A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90107-2410-1 1 in 1 BOX 09/01/2020 1 28 mL in 1 BOTTLE, SPRAY; 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 09/01/2020 Labeler - Adventure Ready Brands (064437304) Registrant - Adventure Ready Brands (064437304) Establishment Name Address ID/FEI Business Operations Adventure Ready Brands 064437304 manufacture(90107-2410)