Label: OLP ANTI-ITCH ALLERGY RELIEF- diphenhydramine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 26, 2018

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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:

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • warnings

    For external use only.

  • do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • Ask a doctor before use

    • on chicken pox
    • on measles
  • WHEN USING

    When using this product avoid contact with eyes

  • Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    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
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • 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

  • PRINCIPAL DISPLAY PANEL

    Anti itch cream

    Net weight 20 g

    NDC#70648-133-01

  • INGREDIENTS AND APPEARANCE
    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)
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