Label: WAL- DRYL ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate cream
- NDC Code(s): 0363-0121-00
- Packager: WALGREENS
- 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 5, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only.
Avoid contact with eyes.
Do not use
- more than directed
- on large areas of the body
- with any product containing diphenhydramine even one taken by mouth
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
-
INGREDIENTS AND APPEARANCE
WAL- DRYL ITCH RELIEF
diphenhydramine hydrochloride and zinc acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 10 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0121-00 1 in 1 CARTON 12/21/2020 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 12/21/2020 Labeler - WALGREENS (008965063) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(0363-0121)