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Radiaderm System Kit

Medically reviewed on March 12, 2018

Dosage form: lotion
Ingredients: DIMETHICONE 2.0g in 100g
Labeler: Water-Jel Technologies
NDC Code: 59898-122

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.

Radiaderm System Kit

Active ingredient

Dimethicone 2.0%

Purpose

Skin Protectant

Uses
  • temporarily protects minor cuts, scrapes, burns
  • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin

Warnings

For external use only

Do not use on
  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply as needed

Other information
  • store at 20 to 25oC (68to 77oF)

Inactive ingredients

water, milk protein, caprylic/capric triglyceride, mineral oil, butylene glucol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, ceteareth-20, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, sodium phosphate, caprylyl glycol, chlorphenesin, dosodium phosphate, disodium EDTA 

1-800-275-3433      info@waterjel.com   www.waterjel.com

Principle Display Panel

RADIADERM SYSTEM KIT  
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-122
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
MINERAL OIL 
BUTYLENE GLYCOL 
GLYCERYL STEARATE SE 
POLYSORBATE 20 
PHENOXYETHANOL 
PEG-100 STEARATE 
TROLAMINE 
ALLANTOIN 
SODIUM PHOSPHATE 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
EDETATE DISODIUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59898-122-3066 PACKET in 1 BOX, UNIT-DOSE
13 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/01/2014
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(59898-122)

 
Water-Jel Technologies

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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