DERMA GRAN  - zinc acetate spray 
Derma Sciences Canada, Inc.

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.

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Drug Facts

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

Other Ingredients:

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


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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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)

Revised: 4/2015
Document Id: 524dd57e-96e2-4c95-a788-7575a7553d99
Set id: 5365f205-986d-4f67-b768-1efaa8e81168
Version: 3
Effective Time: 20150420
 
Derma Sciences Canada, Inc.