DERMA GRAN- zinc acetate spray

DERMA GRAN by

Drug Labeling and Warnings

DERMA GRAN by is a Otc medication manufactured, distributed, or labeled by Derma Sciences Canada, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DERMA GRAN  
zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64772-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64772-127-52	118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/20/2015

Labeler - Derma Sciences Canada, Inc. (200564891)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Sciences Canada, Inc.		200564891	manufacture(64772-127)