ANTI-ITCH- zinc acetate , diphenhydramine cream 
OL PHARMA TECH, 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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Active Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Purpose

Topical analgesic

skin protectant

uses

temporarily relieves pain and itching associated with:

warnings

For external use only

Ask a doctor before use

Do Not Use

When using this product

When using this product avoid contact with eyes

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Do not use more than directed:

protect from excessive heat (40°C/104°F)

Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Questions

drspharmacyusa.com

Directions

do not use more than directed:

Anti itch cream

Itch stopping cream

ANTI-ITCH 
zinc acetate , diphenhydramine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DECYL OLEATE (UNII: ZGR06DO97T)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80489-005-011 in 1 CARTON01/01/2021
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2021
Labeler - OL PHARMA TECH, LLC (021170377)
Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
Establishment
NameAddressID/FEIBusiness Operations
OL PHARMA TECH, LLC Drs PHARMACY021170377manufacture(80489-005)

Revised: 10/2023
Document Id: 06b9a891-604e-a6bb-e063-6394a90a218a
Set id: b79d3096-c609-e710-e053-2995a90a8da2
Version: 3
Effective Time: 20231002
 
OL PHARMA TECH, LLC