Label: DERMA GRAN- 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 April 20, 2015

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  • Active ingredient:

    Zinc Acetate 0.1%

  • Purpose

    Protectant


  • Uses:

    Protects and rehydrates damaged tissue due to rubbing or friction.


  • Warnings

    For external use only.


    Do not use on

    children under 2 years of age without consulting a physician.

    Discontinue use if symptoms persist more than 7 days, and consult a physician.

    Avoid contact with eyes.

    Keep this and all medicines out of children's reach.

  • Directions

    • Apply liberally as often as necessary to abraded skin and irritated areas.
    • Do not wipe, allow to dry.
  • Other Ingredients:

    Alcohol (denatured), Glucose, Methylparaben, Propylparaben, Purified water, Pyridoxine hydrochloride, Sodium chloride, Zinc chloride, Zinc sulfate.


  • SPL UNCLASSIFIED SECTION

    Store at Controlled Room Temperature 15-30 C ( 59-86 F).


  • Principal Display Panel

    DERMA SCiENCES™

    NDC 64772-127-52

    DERMA GRAN®

    MOISTURIZING SPRAY

    pH Balanced

    Skin Protectant

    DM-4

    REORDER No.

    Net Contents 4 fl oz (118 mL)

    Made in Canada

    Derma Sciences, Inc., 104 Shorting Road, Toronto

    Ontario M1S 3S4 Canada

    Questions: In U.S.A. call 1-800-445-7627

    In Canada call: 1-800-387-5302

    Visit our web site at: www.dermasciences.com

    U.S. Patent Number 4,847,083




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  • INGREDIENTS AND APPEARANCE
    DERMA GRAN  
    zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64772-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64772-127-52118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/20/2015
    Labeler - Derma Sciences Canada, Inc. (200564891)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Sciences Canada, Inc.200564891manufacture(64772-127)
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