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

  • NDC Code(s): 68016-163-01
  • Packager: Pharmacy Value Alliance LLC
  • 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 9, 2023

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  • Drug Facts

  • Active Ingredient

    Diphenhydramine Hydrochloride 2%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Zinc Acetate 0.1%

  • Purpose

    Skin Protectant

  • Uses

    For the temporary relief from pain and itcing assciated with:

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritation
    • minor cuts
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries 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 if you have 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
  • Keep out of the reach of children.

    If swallowed, get medical help or contact 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 20°-25°C (68°-77°F)
    • Close cap tightly after use
  • Inactive Ingredients

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

  • Itch Relief Cream Antihistamine Topical Analgesic Skin Protectant

    Temporarily relieves the itching and pain associated with:

    • insect bites
    • allergic itch
    • skin irritations
  • Distributed By:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue

    Wayne, PA. 19087

    www.emersongroup.com

    Product of PRC

  • Packaging

    Itch Relief Cream

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF CREAM 
    zinc acetate 0.1%, diphenhydramine hydrochloride 2% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-163
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LAURETH-23 (UNII: N72LMW566G)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-163-011 in 1 BOX09/01/2016
    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 finalpart34707/19/2016
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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