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
  • 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 February 21, 2022

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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 not finalpart34804/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-023)
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