Label: DERMAMINE EXTRA STRENGTH ITCH STOPPING- diphenhydramine and zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 20, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Diphenhydramine Hydrochloride 2%Topical Analgesic
    Zinc Acetate 0.1%Skin Protectant
  • Uses

    • Temporarily relieves pain and itching associated with:
      • insect bites
      • minor burns
      • sunburn
      • scrapes
      • minor skin irritations
      • minor cuts
      • rashes due to poison ivy, poison oak and 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

    Ask a doctor before use

    • on chicken pox
    • on measles

    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 the reach of children. In case of accidental ingestion, seek medical attention right away 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: ask a doctor
  • Other information

    • store between 15° and 30° C (59° and 86° F)
    • close cap tightly after use
    • do not use if seal on tube is punctured or missing
  • Inactive ingredients

    DMDM Hydantoin, GMS, isopropyl myristate, light mineral oil, methylparaben, propylparaben, ritacol, purified water

  • Questions or comments?

    1-866-323-0107

  • PRINCIPAL DISPLAY PANEL - 35 g Tube Box

    EXTRA STRENGTH

    BLOCKS
    THE ITCH-CAUSING
    HISTAMINES

    Natureplex™

    Dermamine
    Itch Stopping
    Cream
    Topical Analgesic Skin Protectant

    NDC 67234-023-01

    NET WT. 1.25 Oz.(35g)

    Principal Display Panel - 35 g Tube Box
  • INGREDIENTS AND APPEARANCE
    DERMAMINE   EXTRA STRENGTH ITCH STOPPING
    diphenhydramine and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE0.02 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.001 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-023-011 in 1 BOX03/01/2014
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/01/2014
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-023)
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