Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 64cb72ba-fa90-4f5f-a962-643009cd2aac
Route
TOPICAL
Published
Effective Date 2011-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5.0 g)
Inactive Ingredients
Quadrosilan Cyclomethicone 5 Mineral Oil Isopropyl Palmitate Polyglyceryl-4 Isostearate Hexyl Laurate Ethylhexyl Palmitate Glycerin Dimethicone Tocopherol Corn Oil Vitamin A Palmitate Cholecalciferol Yellow Wax Hydrogenated Castor Oil Sodium Chloride Diazolidinyl Urea Methylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2001-01-01
Description

Active Ingredient Zinc oxide 5.0%

Medication Information

Warnings and Precautions

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

Indications and Usage

Uses

Provides temporary relief of itching and discomfort in the perineal area

Dosage and 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.

Description

Active Ingredient Zinc oxide 5.0%

Section 50565-1

Keep out of reach of children

Section 51727-6

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

Section 51945-4

DermaCen

Protectant Cream

A medicated

moisturizing cream

for prevention and

protection of skin

irritations

Net Contents 6 ounces (170g)

Section 55105-1

Purpose

Anorectal Cream

Section 55106-9

Active Ingredient

Zinc oxide 5.0%

Structured Label Content

Indications and Usage (34067-9)

Uses

Provides temporary relief of itching and discomfort in the perineal area

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

DermaCen

Protectant Cream

A medicated

moisturizing cream

for prevention and

protection of skin

irritations

Net Contents 6 ounces (170g)

Section 55105-1 (55105-1)

Purpose

Anorectal Cream

Section 55106-9 (55106-9)

Active Ingredient

Zinc oxide 5.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.588689 · Updated: 2026-03-14T22:55:20.733713