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.

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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

image description

DERMADROX 
aluminum hydroxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1.356 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-221-01113 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/31/2015
Labeler - GERITREX LLC (112796248)
Registrant - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248manufacture(54162-221)

Revised: 8/2017
Document Id: e9a97d88-96fc-4ea0-9482-524aac47716f
Set id: fa0b70c8-50e0-4184-9795-c17739c46630
Version: 3
Effective Time: 20170828
 
GERITREX LLC