Dermadrox
FDA Label NDC 54162-221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Dermadrox (NDC 54162-221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, intended use, directions, warnings, inactive ingredients, otc - keep out of reach of children, storage and handling, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Storage And Handling

Store at room temperature (59'F-86'F).

Keep lid tightly closed.

Dosage & Administration

Reapply at least every 12 hours

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