ITCH RELIEF CREAM- zinc acetate 0.1%, diphenhydramine hydrochloride 2% cream 
Pharmacy Value Alliance LLC

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.

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Itch Relief Cream

Drug Facts

Active Ingredient

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

Uses

For the temporary relief from pain and itcing assciated 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 if you have chicken pox or measles

When using this product avoid contact with eyes.

Stop Use and ask a doctor if

Keep out of the reach of children.

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

Directions

Other Information

Inactive Ingredients

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

Itch Relief Cream
Antihistamine Topical Analgesic Skin Protectant

Temporarily relieves the itching and pain associated with:

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Packaging

Itch Relief Cream

ITCH RELIEF CREAM 
zinc acetate 0.1%, diphenhydramine hydrochloride 2% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-163
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-163-011 in 1 BOX09/01/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/19/2016
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 5/2023
Document Id: fb450e4e-0b92-9b3a-e053-6294a90ae4d7
Set id: 37fe6d82-adee-4f58-e054-00144ff88e88
Version: 7
Effective Time: 20230509
 
Pharmacy Value Alliance LLC