DERMA GRAN- aluminium hydroxide ointment

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 Ingredients:

Aluminium Hydroxide Gel  0.275%

Purpose

Skin Protectant

Uses:

• 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.
  

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

• pH Balanced
• Skin Protectant
• Latex Free
  

4 FL OZ (113 g)

DERMA GRAN

OINTMENT

NDC: 64771-126-34

• pH Balanced
• Skin Protectant
• Latex Free

INGREDIENTS AND APPEARANCE

DERMA GRAN  
aluminium hydroxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64772-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALGELDRATE (UNII: 03J11K103C) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALGELDRATE	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: 64772-126-36	113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64772-126-34	113 g in 1 JAR; 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	06/16/2015

Labeler - Derma Sciences Canada, Inc. (200564891)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Sciences Canada, Inc.		200564891	manufacture(64772-126)