NDC | 68016-163-01 |
Set ID | 37fe6d82-adee-4f58-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmacy Value Alliance LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
- Warnings
- Stop Use and ask a doctor if
- Keep out of the reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Itch Relief Cream Antihistamine Topical Analgesic Skin Protectant
- Distributed By:
- Packaging
-
INGREDIENTS AND APPEARANCE
ITCH RELIEF CREAM
zinc acetate 0.1%, diphenhydramine hydrochloride 2% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-163 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 METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) LAURETH-23 (UNII: N72LMW566G) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-163-01 1 in 1 BOX 09/01/2016 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 final part347 07/19/2016 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - Trifecta Pharmaceuticals USA (079424163)