Label: DERMAGESIC- pramoxine hcl, zinc oxide, calamine 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 June 23, 2016

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  • Active Ingredients

    Pramoxine HCl 1%

    Zinc Oxide 0.4%

    Calamine 0.4%

  • Purpose

    Anestheric/Analgesic

    Skin Protectant

  • Uses

    • for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
  • Warnings

    For external use only. Avoid contact with the eyes

    • Not for Pediatric use
    • Hypersensitivity to "caine" anesthetics

    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

    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 REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions 

    • 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
    • Do not use more often than directed
  • Inactive Ingredients

    Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

  • Questions or Comments

    1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    Dermagesic Cream

  • INGREDIENTS AND APPEARANCE
    DERMAGESIC 
    pramoxine hcl, zinc oxide, calamine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 mg  in 1 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-202-04113 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34704/01/2016
    Labeler - Llorens Pharmaceutical International Division (037342305)