Dermadrox: Package Insert and Label Information

DERMADROX- aluminum hydroxide ointment
GERITREX LLC

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.

Drug Facts

Active Ingredients Purpose

Aluminum Hydroxide………………………..1.2% A Skin protectant

Intended Use

Used for relief of minor skin irritations such as chafing, Interigo and galling.

Provides temporary relief to abraded skin, friction burns and rubbing.

Lubricates effectively on psoriatic skin.

Effective for dried cracked skin, sunburn and abraded skin

Directions

Apply liberally as often as necessary to minor burns, abraded skin,

irritated areas and minor wounds.

Reapply at least every 12 hours.

Warnings

For External Use Only

Avoid contact with eyes

Discontinue use if symptoms persist for more than 7 days.

DERMADROX ointment is contraindicated in patients with a

history of hypersensitivity to any of its components.

Inactive Ingredients

Calcium Carbonate, Citric acid, Deionized water, Glycerin, Lanolin, Lanolin Alcohol,

Mangnesium hydroxide, Methyl and propyl parabens, Mineral oil, Petrolatum,

Sodium chloride, Sodium laureth sulfate, Stearyl alcohol, Vitamin A and D in a

Hydrophilic ointment base, Zinc chloride.

Keep out of reach of children

Store at room temperature (59’F-86’F).

Keep lid tightly closed.

Reapply at least every 12 hours

DERMADROX aluminum hydroxide ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-221 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 1.356 g in 113 g

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE CITRIC ACID ACETATE WATER GLYCERIN LANOLIN LANOLIN ALCOHOLS MAGNESIUM HYDROXIDE METHYLPARABEN PROPYLPARABEN MINERAL OIL PETROLATUM SODIUM CHLORIDE SODIUM LAURETH SULFATE STEARYL ALCOHOL VITAMIN A VITAMIN D ZINC CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54162-221-01 113 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/31/2015

Labeler — GERITREX LLC (112796248)

Registrant — GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Operations
GERITREX LLC		112796248	manufacture (54162-221)

Revised: 08/2017 GERITREX LLC