DermaCen Protectant

Dosage form: cream
Ingredients: ZINC OXIDE 5.0g in 100g
Labeler: Central Solutions Inc
NDC Code: 62654-313

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)

DERMACEN PROTECTANT 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-313
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
QUADROSILAN 
CYCLOMETHICONE 5 
MINERAL OIL 
ISOPROPYL PALMITATE 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
ETHYLHEXYL PALMITATE 
GLYCERIN 
DIMETHICONE 
TOCOPHEROL 
CORN OIL 
VITAMIN A PALMITATE 
CHOLECALCIFEROL 
YELLOW WAX 
HYDROGENATED CASTOR OIL 
SODIUM CHLORIDE 
DIAZOLIDINYL UREA 
METHYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:62654-313-06170 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2001
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIOperations
Central Solutions Inc007118524manufacture

Revised: 09/2011
 
Central Solutions Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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