OLP ANTI-ITCH ALLERGY RELIEF- diphenhydramine cream 
OHIO LAB PHARMA 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%

Topical analgesic

skin protectant

Uses

temporarily relieves pain and itching associated with:

warnings

For external use only.

do not use

Ask a doctor before use

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

Other information

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

inactive ingredients

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

Questions

www.ohiolabpharma.us

Anti itch cream

Net weight 20 g

NDC#70648-133-01

OLP ANTI-ITCH ALLERGY RELIEF 
diphenhydramine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DECYL OLEATE (UNII: ZGR06DO97T)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70648-133-011 in 1 CARTON02/21/2018
120 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 finalpart34802/21/2018
Labeler - OHIO LAB PHARMA LLC. (080215854)
Establishment
NameAddressID/FEIBusiness Operations
OHIO LAB PHARMA LLC.080215854manufacture(70648-133)

Revised: 11/2018
Document Id: 7b9c7090-9720-809c-e053-2a91aa0ab42d
Set id: 65d4acc8-6936-3fd3-e053-2991aa0ab3d3
Version: 2
Effective Time: 20181126
 
OHIO LAB PHARMA LLC.