DERMACEN PROTECTANT- zinc oxide cream 
Central Solutions Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient

Zinc oxide 5.0%

Purpose

Anorectal Cream

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 promptly

Keep out of reach of children

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 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

DermaCen

Protectant Cream

A medicated

moisturizing cream

for prevention and

protection of skin

irritations

Net Contents 6 ounces (170g)

container label

DERMACEN PROTECTANT 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62654-313-06170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2001
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture(62654-313)

Revised: 12/2018
Document Id: 283710c4-f9f7-4f91-898e-a538eb3c08be
Set id: 64cb72ba-fa90-4f5f-a962-643009cd2aac
Version: 2
Effective Time: 20181206
 
Central Solutions Inc