DERMADROX- aluminum hydroxide ointment 
GERITREX CORP

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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Dermadrox Ointment

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

DAT4

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 (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 1.2 g  in 100 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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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:54162-221-01 113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part346 01/30/2013
Labeler - GERITREX CORP (112796248)
Registrant - GERITREX CORP (112796248)
Establishment
Name Address ID/FEI Business Operations
GERITREX CORP 112796248 manufacture(54162-221)

Revised: 1/2013
Document Id: 4125d0cc-d84e-484d-a7ba-d986739bdace
Set id: fa0b70c8-50e0-4184-9795-c17739c46630
Version: 1
Effective Time: 20130130
 
GERITREX CORP