Label: GENRX SKIN BARRIER- dimethicone cream

  • NDC Code(s): 59088-851-01, 59088-851-05, 59088-851-08, 59088-851-69
  • Packager: PureTek Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Dimethicone 1.5%

    Purpose

    Skin Protectant

    Close
  • Uses

    ■ for the treatment and/or prevention of diaper rash
    ■ temporarily protects and helps relieve chapped or cracked skin

    Close
  • 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 last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

    Close
  • Directions

    ■ apply liberally as needed

    Close
  • Other information

    ■ protect from freezing    ■ avoid excessive heat

    Close
  • Skin Barrier Cream with GenRx Complex​TM (4 oz tube label)
  • INGREDIENTS AND APPEARANCE
    GENRX SKIN BARRIER 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-851
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 15 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    C12-13 PARETH-3 (UNII: DMC6N3419L)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GINGER (UNII: C5529G5JPQ)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-851-69 144 in 1 CARTON
    1 NDC:59088-851-01 4 mL in 1 POUCH
    2 NDC:59088-851-05 59 mL in 1 TUBE
    3 NDC:59088-851-08 118 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/08/2013
    Labeler - PureTek Corporation (785961046)
    Establishment
    Name Address ID/FEI Business Operations
    PureTek Corporation 785961046 manufacture(59088-851) , pack(59088-851) , label(59088-851)
    Close