Label: ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream

  • NDC Code(s): 52000-023-37, 52000-023-39
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Diphenhydramine Hydrochloride  2%

    Zinc Acetate  0.1%

  • PURPOSE

    Purpose

    Topical Analgesic

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain and itching associated with:

    • minor skin irritation
    • allergic itches
    • rashes
    • hives
    • minor burns
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use on children under 2 years of age.

    For external use only

    • avoid contact with eyes
    • do not apply to open wound or damaged skin.
  • STOP USE

    Stop use and ask a doctor

    • if condition worsens
    • symptoms persist for 7 days or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    • For children under 2 years of age: consult a physician.

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at 20ºC to 25ºC (68ºF to 77ºF).
  • INACTIVE INGREDIENT

    Inactive ingredients

    Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Anti-Itch Cream

    NET WT 1 OZ (28 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE0.02 g  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-023-371 in 1 BOX02/14/2022
    1NDC:52000-023-3928 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
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