Label: ANTI-ITCH- zinc acetate , diphenhydramine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2025

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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

  • Ask a doctor before use

    • on chicken pox
    • on measles
  • Do Not Use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • When using this product

    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 SAFETY INFORMATION

    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:

    • 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
  • PRINCIPAL DISPLAY PANEL

    Anti itch cream

    Itch stopping cream

  • INGREDIENTS AND APPEARANCE
    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 DrugM01601/01/2021
    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)
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