Label: DG ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate 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 December 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Diphenhydramine hydrochloride 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • Uses

    Temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • sunburn
    • scrapes
    • minor skin irritations
    • minor cuts

    Dries the oozing and weeping of poison ivy, poison oak and poison sumac

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do Not Use

    • more than directed
    • on large areas of the body
    • with any product containing diphenhydramine even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • do not use more than directed
    • adults and children 2 years of age and older: apply to affected area up to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • contents filled by weight, not volume
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    cetearyl alcohol (and) polysorbate 60, DMDM hydantoin, glyceryl stearate, isopropyl myristate, mineral oil, phenoxy ethenol, purified water, sodium benzoate

  • Questions or comments?

    1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY OLD
    EAST MAIN CO.,
    100 MISSION RIDGE
    GOODLETTSVILLE, TN
    37072

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    DG™|health

    NDC 55910-344-24

    Compare to
    active
    ingredients
    of Benadryl®
    Extra
    Strength
    Cream*

    Extra Strength
    Anti-Itch
    Cream
    Topical Analgesic
    and Skin Protectant

    Relieves Itches
    From Insect Bites
    & Skin Irritations

    NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DG ANTI-ITCH 
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-344
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) Diphenhydramine hydrochloride20 mg  in 1 g
    Zinc acetate (UNII: FM5526K07A) (zinc cation - UNII:13S1S8SF37) Zinc acetate0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    mineral oil (UNII: T5L8T28FGP)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-344-241 in 1 CARTON10/19/2017
    128 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 finalpart34805/17/2011
    Labeler - Dollar General (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(55910-344)
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