DERMACEN PROTECTANT- zinc oxide cream

DermaCen Protectant by

Drug Labeling and Warnings

DermaCen Protectant by is a Otc medication manufactured, distributed, or labeled by Central Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc oxide 5.0%

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

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

PRINCIPAL DISPLAY PANEL

DermaCen

Protectant Cream

A medicated

moisturizing cream

for prevention and

protection of skin

irritations

Net Contents 6 ounces (170g)

INGREDIENTS AND APPEARANCE

DERMACEN PROTECTANT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
QUADROSILAN (UNII: C5KT601WPM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-313-06	170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/2001

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-313)