RADIADERM STARTER KIT (DIMETHICONE) LOTION [WATER-JEL TECHNOLOGIES]

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RADIADERM STARTER KIT (DIMETHICONE) LOTION [WATER-JEL TECHNOLOGIES]
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NDC 59898-123-31
Set ID 99074755-f6ae-4f78-a9b2-6f4a78d2a0ce
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies
Generic Name
Product Class
Product Number
Application Number PART332
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  • 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 25 oC (68 to 77 oF)
  • 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 

  • QUESTIONS

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

  • Principle Display Panel

    image description
  • INGREDIENTS AND APPEARANCE
    RADIADERM STARTER KIT 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-123-3110 in 1 BOX, UNIT-DOSE02/01/201408/01/2018
    13 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/01/2014
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-123)
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