DERMA GRAN  - aluminium hydroxide ointment 
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 Ingredients:

Aluminium Hydroxide Gel  0.275%


Purpose

Skin Protectant


Uses:

Warnings:

For external use only.

Avoid contact with eyes.

Not to be applied over deep or puncture wounds, infections or  lacerations. Consult a physician.

If condition worsens or does not improve within 7 days stop use and consult a physician.

Do not use on

children under 6 months of age without consulting a physician.


Keep this and all medicines out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


Directions

Cleanse area and dry thoroughly. Apply as needed, directly to the affected area.


Other Ingredients:

Calcium carbonate, Lanolin, Magnesium hydroxide, Methlyparaben, Petrolatum, Propylene glycol, Propylparaben, Sodium Chloride, Sodium Lauryl Sulfate, Stearyl alcohol, Vitamin A Palmitate, Water, Zinc Chloride.


Customer Storage:

Store at a Controlled Room Temperature 15-30o(59-86oF)


Principal Display Panel

DERMA GRAN

OINTMENT

NDC 64772-126-36

4 FL OZ (113 g)

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DERMA GRAN

OINTMENT

NDC 64771-126-34




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DERMA GRAN  
aluminium hydroxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64772-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALGELDRATE (UNII: 03J11K103C) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALGELDRATE0.275 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
LANOLIN (UNII: 7EV65EAW6H)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
WATER (UNII: 059QF0KO0R)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64772-126-36113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:64772-126-34113 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/16/2015
Labeler - Derma Sciences Canada, Inc. (200564891)
Establishment
NameAddressID/FEIBusiness Operations
Derma Sciences Canada, Inc.200564891manufacture(64772-126)

Revised: 6/2015
Document Id: febc98f6-5fa6-477b-bfa1-ec1011805653
Set id: aecee847-78f9-46f0-9eb2-4b79c2a49dd5
Version: 4
Effective Time: 20150616
 
Derma Sciences Canada, Inc.