DERMADROX- aluminum hydroxide ointment

Dermadrox by

Drug Labeling and Warnings

Dermadrox by is a Otc medication manufactured, distributed, or labeled by GERITREX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients                    Purpose

Aluminum Hydroxide Gel         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

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, Magnesium Hydroxide, Mineral Oil,

Petrolatum, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Vitamin A and D, Zinc Chloride

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Storage

Store at room temperature (59'F-86'F) Keep lid tightly closed

DOSAGE & ADMINISTRATION

Reapply at least every 12 hours

Direction

Apply liberally as often as necessary to minor burns, abraded skin, irritated areas and minor wounds

Reapply at least every 12 hours

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMADROX 
aluminum hydroxide ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	1.356 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
ZINC CHLORIDE (UNII: 86Q357L16B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-221-04	113 g in 1 JAR; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/15/2013

Labeler - GERITREX LLC (112796248)

Registrant - GERITREX LLC (112796248)

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