Active ingredient

Zinc Oxide 5.0%

Purpose

Anorectal

Uses

Provides temporary relief of itching and discomfort in the perineal area

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

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

Questions?

Call 800-255-0262

Keep out of reach of children.

DermaCen

Skin

Protectant

Cream

Conains Zinc

Oxide with

Vitamins A,D, and E

Net Contents:

6 fl oz (177.4 mL)

DCSPC label

DERMACEN SKIN PROTECTANT
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62654-148
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
YELLOW WAX (UNII: 2ZA36H0S2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62654-148-06	177.4 mL in 1 TUBE; Type 0: Not a Combination Product	12/06/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	12/06/2019

Labeler - Central Solutions Inc (007118524)

Name	Address	ID/FEI	Business Operations
Establishment
Central Solutions Inc		007118524	manufacture(62654-148)