Label: DERMADROX- zinc acetate spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 31, 2015

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  • Active                                 Zinc Acetate 0.45%           

  • Purpose:

    Skin protectant/Astringent

  • Intended Use:

    Rehydrates damaged tissues and protects chaffed,  chapped, cracked, or burned skin.

  • Warnings:

    For External Use Only​Discontinue use if symptoms persist for more than 7 days and consult a physician
    Do not use on children under 6 years of age without consulting a physician

  • ​KEEP OUT OF REACH OF CHILDREN

  • ​Avoid contact with eyes​

  • Directions

    Apply generously as often as necessary to minor burns, abraded skin, irritated areas and minor wounds.
    Spray directly on the affected area with a thin coat of Dermadrox
    Reapply at least every 12 hours. May be used as a wet dressing

  • Inactive Ingredients

    Alcohol, Citric Acid, Corn Syrup, Purified Water, Pyridoxine HCL, Sodium Benzoate, Sodium Chloride

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DERMADROX 
    zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.531 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-220-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-220)
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