DermaCen Skin Protectant

Manufacturer
Central Solutions Inc
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:41:29

Label at a glance#

ProductDermaCen Skin Protectant
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Provides temporary relief of itching and discomfort in the perineal area

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5.0%

Purpose

OTC - PURPOSE SECTION

Anorectal

Uses

INDICATIONS & USAGE SECTION

Provides temporary relief of itching and discomfort in the perineal area

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 800-255-0262

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaCen

Skin

Protectant

Cream

Conains Zinc

Oxide with

Vitamins A,D, and E

Net Contents:

6 fl oz (177.4 mL)

DCSPC label DCSPC labelDCSPC label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1191136zinc oxide 5 % Rectal CreamPSN3
1191136zinc oxide 50 MG/ML Rectal CreamSCD3
1191136zinc oxide 5 % Rectal CreamSY3
1191136ZNO 50 MG/ML Rectal CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62654-148-06DermaCen Skin Protectant177.4 mL in 1 TUBECREAM177.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62654-148DERMACEN SKIN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]3Current NDC, Legacy NDC, 1 package rows20241210_990c3a65-bca5-1f0d-e053-2995a90aa7ae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62654-14862654-148-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaCen Skin ProtectantZINC OXIDECentral Solutions Inc990c3a65-bca5-1f0d-e053-2995a90aa7ae2024-12-09WarningsExact identifier
ndc (package): 62654-148-06
ndc (product): 62654-148
ndc11 (package): 62654014806
spl id: 28d9d9d5-00f4-c88e-e063-6294a90a5c31
spl set id: 990c3a65-bca5-1f0d-e053-2995a90aa7ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.