NDC Code(s) : 69396-025-05, 69396-025-15
Packager : Trifecta Pharmaceuticals USA, LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anti-Itch CreamDiphenhydramine hydrochloride 2%, zinc acetate 0.1% CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-025
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE2 g in 100 g
ZINC ACETATE(UNII: FM5526K07A)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC ACETATE0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LAURETH-23(UNII: N72LMW566G)
WATER(UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PETROLATUM(UNII: 4T6H12BN9U)
MINERAL OIL(UNII: T5L8T28FGP)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69396-025-051 in 1 BOX 29/12/2016
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:69396-025-151 in 1 BOX 02/11/2020
242 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 Drug M017 12/29/2016

LABELER - Trifecta Pharmaceuticals USA, LLC.(079424163)

PRINCIPAL DISPLAY PANEL

Globe Anti-itch Cream 1.5oz Rev10 062422 CDER