DERMA GRAN  - aluminum hydroxide ointment 
McKesson Medical-Surgical

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

MCKESSON

DERMA GRAN
OINTMENT
NDC 68599-6103-3



MFR # 61-DT4
4
FL OZ ( 113 g)


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DERMA GRAN  
aluminium hydroxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-6103
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 0.275 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:68599-6103-3 113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 11/12/2013
Labeler - McKesson Medical-Surgical (023904428)
Establishment
Name Address ID/FEI Business Operations
Derma Sciences Canada, Inc. 200564891 manufacture(68599-6103)

Revised: 11/2013
Document Id: a29c9af0-87d1-4212-a429-ba11e14e6d73
Set id: 464bdaf6-e64b-401f-9d14-f6148bb16653
Version: 2
Effective Time: 20131112
 
McKesson Medical-Surgical