Dermadrox
FDA Label NDC 54162-220

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 54162-220). 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 active                                 zinc acetate 0.45%, purpose:, intended use:, warnings:, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active                                 Zinc Acetate 0.45%

Purpose:

Skin protectant/Astringent

Intended Use:

Rehydrates damaged tissues and protects chaffed,  chapped, cracked, or burned skin.

Warnings:

For External Use Only​Discontinue use if symptoms persist for more than 7 days and consult a physician
Do not use on children under 6 years of age without consulting a physician

Directions

Apply generously as often as necessary to minor burns, abraded skin, irritated areas and minor wounds.
Spray directly on the affected area with a thin coat of Dermadrox
Reapply at least every 12 hours. May be used as a wet dressing

Inactive Ingredients

Alcohol, Citric Acid, Corn Syrup, Purified Water, Pyridoxine HCL, Sodium Benzoate, Sodium Chloride

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