Label: DERMAGESIC- pramoxine hcl, zinc oxide, calamine liquid

  • NDC Code(s): 54859-120-04
  • Packager: Llorens Pharmaceuticals International Division
  • 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 December 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients                   Purpose

    Pramozine HCl .... 1% ............ Anesthetic/Analgesic

    Zinc Oxide .........0.4% ............ Skin Protectant

    Calamine ...........0.4% ............ Skin Protectant

  • PURPOSE

    Purpose

    Anesthetic/Analgesic

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    • For external use only. Avoid contact with the eyes
    • Not for Pediatric use
    • Hypersensitivity to "caine" anesthetics
  • DO NOT USE

    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.

  • DOSAGE & ADMINISTRATION

    Directions  SHAKE WELL

    • 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 INGREDIENT

    Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

  • QUESTIONS

    Questions:  1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    DermagesicLabel

  • INGREDIENTS AND APPEARANCE
    DERMAGESIC 
    pramoxine hcl, zinc oxide, calamine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.4 mg  in 100 mL
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-120-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/01/2014
    Labeler - Llorens Pharmaceuticals International Division (037342305)
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