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.

----------

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54162-221
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE1.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-221-01113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34601/30/2013
Labeler - GERITREX CORP (112796248)
Registrant - GERITREX CORP (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX CORP112796248manufacture(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