ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC]

ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC]
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NDC 68016-163-01
Set ID 37fe6d82-adee-4f58-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Pharmacy Value Alliance LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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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