Pill Identifier App

Revitaderm 40

Dosage form: gel
Ingredients: UREA 40g in 100g
Labeler: Blaine Labs Inc.
NDC Code: 63347-102

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredients

Urea - 40%

Inactive Ingredients

C-12-C-15 Alkyl Benzoate, Carthamus Tinctorius Seed Oil, Cetyl Alcohol, Dimethicone, Emulsifying Wax, Glycerin, Glyceryl Sterate, Melaleuca Alternifolia (Tea Tree) oil, PEG 100 Stearate, Phenonip, Propylene Glycol, Water

Purpose

Medical Strength Care for Thick, Dry Callused Skin

UsesRevitaderm 40 is a complete callus-care solution formulated to remove thick callused areas while re-hydrating skin to a healthy appearance.  Revidaderm 40 with 40% Urea is recommended for use by diabetics when under the supervision of a physician.

Keep Out of Reach of ChildrenKeep Out Of The Reach Of Children


Directions

Apply as needed to dry skin areas.  Best applied to affected areas immediately after showering and just before bedtime.  Use the supplied pumice stone and brush as needed to remove dead skin.

Warnings

Should signs of irritation develop, discontinue use.  Do not use pumice stone or brush on open wounds, cracked or bleeding skin.  For external use only.  Avoid contact with th eyes.

RevitaDERM 40 LabelRevitaDERM 40
Physician Formula  The complete callus-care solution  Infused with Aloe Vera P2000, Tea Tree Oil, Chamomile
Net Wt 4.0 oz (112 gr)


REVITADERM 40 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA) UREA40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE 
SAFFLOWER OIL 
CETYL ALCOHOL 
DIMETHICONE 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
PEG-150 DISTEARATE 
STEARETH-20 
GLYCERIN 
GLYCERYL MONOSTEARATE 
TEA TREE OIL 
PEG-100 STEARATE 
PHENOXYETHANOL 
METHYLPARABEN 
BUTYLPARABEN SODIUM 
ETHYLPARABEN, SODIUM SALT 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER  
Packaging
#Item CodePackage Description
1NDC:63347-102-01112 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1995
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture

Revised: 03/2011
 
Blaine Labs 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.

Hide
(web1)