Dermacen Protectant
FDA Label NDC 62654-313

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Solutions Inc for the product Dermacen Protectant (NDC 62654-313). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Zinc oxide 5.0%

Otc - Purpose

Purpose

Anorectal Cream

Indications & Usage

Uses

Provides temporary relief of itching and discomfort in the perineal area

Warnings

Warnings

For External Use Only

If condition worsens or does not improve within 7 days, consult a physician

Do not exceed the recommended daily dosage unless directed by a physician

In case of bleeding, consult a physician promptly

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Dosage & Administration

Directions

When practical, clean the affected area by patting or blotting with an appropriate cleaning pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply DermaCen Protectant Cream externally to the affected area.

Inactive Ingredient

Inactive Ingredients

Purified Water, Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Ethylhexyl Palmitate, Glycerin, Cetyl Dimethicone, Dimethicone, Tocopherol, Zea Mays Oil, Retinyl Palmitate, Cholecalciferol, Beeswax, Hydrogenated Castor Oil, Sodium Chloride, Diazolidinyl Urea, Methyl Paraben

Package Label.Principal Display Panel

DermaCen

Protectant Cream

A medicated

moisturizing cream

for prevention and

protection of skin

irritations

Net Contents 6 ounces (170g)

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