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

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  • Uses

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

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  • 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.

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  • Directions

    ■ apply liberally as needed

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  • Other information

    ■ protect from freezing    ■ avoid excessive heat

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  • Inactive ingredients

    Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, C12-13 pareth-23, C12-13 pareth-3, Carthamus tinctorius (safflower) seed oil, cetyl dimethicone, cyclopentasiloxane, dicaprylyl carbonate, dimethiconol, divinyldimethicone/dimethicone copolymer, fragrance, GenRx Complex™ [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG/PPG-18/18 dimethicone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, propylene glycol, propylheptyl caprylate, purified water, sodium chloride, sodium hyaluronate.

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  • 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 LABEL Item Code (Source) NDC:59088-851
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 15 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL  
    ALOE VERA LEAF  
    C12-13 PARETH-23  
    C12-13 PARETH-3  
    SAFFLOWER OIL  
    CYCLOMETHICONE 5  
    DICAPRYLYL CARBONATE  
    DIMETHICONOL (40 CST)  
    LEVOMENOL  
    CALCIUM PANTOTHENATE  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES  
    MALTODEXTRIN  
    NIACINAMIDE  
    PYRIDOXINE HYDROCHLORIDE  
    SILICON DIOXIDE  
    SODIUM ASCORBYL PHOSPHATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    GINGER  
    PEG/PPG-18/18 DIMETHICONE  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)  
    PHENOXYETHANOL  
    PROPYLENE GLYCOL  
    PROPYLHEPTYL CAPRYLATE  
    WATER  
    SODIUM CHLORIDE  
    HYALURONATE SODIUM  
    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)
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