ANTI-ITCH CREAM- diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream 
Trifecta Pharmaceuticals USA, LLC.

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Anti-Itch Cream

Active Ingredient

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

For the temporary relief from pain and itching associated with

Warnings

For External Use Only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use on chicken pox or measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

Stop use and ask a doctor

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Other information

Questions? Call 1-888-296-9067

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

Globe Anti-itch Cream 1.5oz Rev10 062422 CDER

ANTI-ITCH CREAM 
diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-025-051 in 1 BOX12/29/2016
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-025-151 in 1 BOX02/11/2020
242 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/29/2016
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 1/2024
Document Id: 0df7f83e-5adb-ec48-e063-6294a90a198e
Set id: 44d17651-a31b-64ca-e054-00144ff8d46c
Version: 5
Effective Time: 20240102
 
Trifecta Pharmaceuticals USA, LLC.