Label: ANTI ITCH TOPICAL ANALGESIC- diphenhydramine hydrochloride, 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 April 3, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Diphenhydramine HCI 2%........................................................Topical analgesic

    Zinc acetate, 0.1%.................................................................... Skin protectant

  • PURPOSE

    Uses

    • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • minor skin irritations
    • sunburn
    • minor cuts
    • scrapes
    • rashes due to poison ivy, oak, and sumac
    • dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • with any other product containing diphenhydramine, even one taken by mouth
    • on large areas of the body
  • ASK DOCTOR

    Ask a doctor before use

    • on chicken pox
    • on measles
  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

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

  • 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

  • INDICATIONS & USAGE

    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

  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from excessive heat (40°C/104°F), humidity, and light
  • INACTIVE INGREDIENT

    inactive ingredients

    cetostearyl alcohol, glyceryl stearate/peg-100 stearate, methylparaben, propylene glycol, propylparaben, purified water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    C.D.M.A. INC.

    43157 W. 9 Mile Road

    Novi, MI 48375

    www.qualitychoice.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    PH

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH TOPICAL ANALGESIC 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-731-281 in 1 CARTON04/03/2020
    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 finalpart34804/03/2020
    Labeler - Chain Drug Marketing Associations Inc (011920774)
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