Label: ANTI-ITCH CREAM- diphenhydramine hydrochloride 2%, zinc acetate 0.1% 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 May 25, 2023

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  • Active Ingredient

    Diphenhydramine Hydrochloride 2%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Zinc Acetate 0.1%

  • Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    For the temporary relief from pain and itching associated with

    • insect bites
    • minor burns
    • minor skin irritation
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the weeping and oozing of poison ivy, oak and sumac
  • Warnings

    For External Use Only

    Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

    Ask a doctor before use on chicken pox or measles

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • Conditions worsen or do not improve within 7 days
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Stop use and ask a doctor

    • Conditions worsen or do 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 the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • 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: consult a doctor
  • Other information

    • Store at controlled room temperature 20º-25ºC (68º-77ºF)
    • Close cap tightly after use

    Questions? Call 1-800-935-2362

  • Inactive Ingredients

    Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

  • Distributed By

    Distributed by CDMA Inc.

    43157 W 9 Mile Road

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    Product of PRC

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company owner of the registered trademark Benadryl.

  • Packaging

    QC anti-itch-extra-strength-1oz

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH CREAM 
    diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-683
    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
    LAURETH-23 (UNII: N72LMW566G)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-683-011 in 1 BOX08/14/2020
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/14/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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