Label: DERMADROX- aluminum hydroxide ointment
- NDC Code(s): 54162-221-01
- Packager: GERITREX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 28, 2017
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- Drug Facts
Active Ingredients Purpose
Aluminum Hydroxide.............................1.2% A Skin protectantClose
- 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 skinClose
Apply liberally as often as necessary to minor burns, abraded skin,
irritated areas and minor wounds.
Reapply at least every 12 hours.Close
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.Close
- 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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of childrenClose
- STORAGE AND HANDLING
Store at room temperature (59'F-86'F).
Keep lid tightly closed.Close
- DOSAGE & ADMINISTRATION
Reapply at least every 12 hoursClose
- INGREDIENTS AND APPEARANCE
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) 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; 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 07/31/2015 Labeler - GERITREX LLC (112796248) Registrant - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-221)