Label: DERMA GRAN - aluminum hydroxide ointment
- NDC Code(s): 68599-6103-3
- Packager: McKesson Medical-Surgical
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredients:
Aluminium Hydroxide Gel 0.275%
- Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac.
- For the temporary protection, comfort and lubrication of minor skin irritations such as intertrigo, chafing, galling, rubbing or friction.
For external use only.
Avoid contact with eyes.
Not to be applied over deep or puncture wounds, infections or lacerations. Consult 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.
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
- pH Balanced
- Skin Protectant
- Latex Free
MFR # 61-DT4
4 FL OZ ( 113 g)
- INGREDIENTS AND APPEARANCE
aluminium hydroxide ointment
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-6103 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 0.275 g in 100 g Inactive Ingredients Ingredient Name Strength 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 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)