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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68599-6103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE0.275 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
LANOLIN 
MAGNESIUM HYDROXIDE 
METHYLPARABEN 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CHLORIDE 
SODIUM LAURYL SULFATE 
STEARYL ALCOHOL 
VITAMIN A PALMITATE 
WATER 
ZINC CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-6103-3113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/12/2013
Labeler - McKesson Medical-Surgical (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Derma Sciences Canada, Inc.200564891manufacture(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