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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 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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