Drug Facts 62654-148

Drug Facts 62654-148
SPL v3
SPL
SPL Set ID 990c3a65-bca5-1f0d-e053-2995a90aa7ae
Route
TOPICAL
Published
Effective Date 2019-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (50 mg)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Cyclomethicone 5 Cyclomethicone 4 Dimethicone Dmdm Hydantoin Ethylhexyl Palmitate Glycerin Hexyl Laurate Polyglyceryl-4 Isostearate Water Sodium Chloride Tocopherol Cetyl Dimethicone 25 Hydrogenated Castor Oil Vitamin A Palmitate Corn Oil Iodopropynyl Butylcarbamate Isopropyl Palmitate Cholecalciferol Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-06
Description

Zinc Oxide 5.0%

Purpose

Anorectal

Medication Information

Purpose

Anorectal

Description

Zinc Oxide 5.0%

Uses

Provides temporary relief of itching and discomfort in the perineal area

Section 50565-1

Keep out of reach of children.

Section 51945-4

DermaCen

Skin

Protectant

Cream

Conains Zinc

Oxide with

Vitamins A,D, and E

Net Contents:

6 fl oz (177.4 mL)

DCSPC label

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 immediately
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 Skin Protectant Cream externally to affected area

Questions?

Call 800-255-0262

Active Ingredient

Zinc Oxide 5.0%

Inactive Ingredients

Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol (Vitamin D3), Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, DMDM Hydantoin, Ethylhexyl Palmitate, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Isopropyl palmitate, Polyglyceryl-4 Isostearate, Putified Water, Retinyl Palmitate (Vitamin A), Sodium Chloride, Tocopherol (Vitamin E), Zea Mays Oil

Structured Label Content

Uses

Provides temporary relief of itching and discomfort in the perineal area

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

DermaCen

Skin

Protectant

Cream

Conains Zinc

Oxide with

Vitamins A,D, and E

Net Contents:

6 fl oz (177.4 mL)

DCSPC label

Purpose

Anorectal

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 immediately
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 Skin Protectant Cream externally to affected area

Questions?

Call 800-255-0262

Active Ingredient (Active ingredient)

Zinc Oxide 5.0%

Inactive Ingredients (Inactive ingredients)

Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol (Vitamin D3), Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, DMDM Hydantoin, Ethylhexyl Palmitate, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Isopropyl palmitate, Polyglyceryl-4 Isostearate, Putified Water, Retinyl Palmitate (Vitamin A), Sodium Chloride, Tocopherol (Vitamin E), Zea Mays Oil

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.788113 · Updated: 2026-03-14T23:05:34.774689