Label: ANTI-ITCH- diphenhydramine hcl, zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 17, 2023

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  • Active ingredients (in each gram)

    Diphenhydramine HCl 2%

    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 or poison sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  • Warnings

    For external use only.

    Do not use

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

    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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not use more often 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 information

    • store at 20° - 25°C (68° - 77°F)
  • Inactive ingredients

    cetearyl alcohol, ethylparaben, glycerin, glyceryl stearate, mineral oil, polysorbate 80, propylene glycol, stearic acid, stearyl alcohol, water

  • Questions or Comments?

    1-800-883-0085

  • Package label

    Anti-Itch Cream

    carton

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    diphenhydramine hcl, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0633
    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
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0633-21 in 1 BOX12/13/2013
    156.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/13/2013
    Labeler - Kareway Product, Inc. (121840057)
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