Label: ANTI-ITCH CREAM- diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream

  • NDC Code(s): 69396-025-05, 69396-025-15
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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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 1-888-296-9067

  • 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:

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    Product of PRC

    www.trifecta-pharma.com

  • Packaging

    Globe Anti-itch Cream 1.5oz Rev10 062422 CDER

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH CREAM 
    diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-025
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-025-051 in 1 BOX12/29/2016
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-025-151 in 1 BOX02/11/2020
    242 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/29/2016
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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