Label: ANTI-ITCH- zinc acetate , 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 October 2, 2023

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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 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)
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