Label: GENRX DAILY DEFENSE SKIN REPAIRING- dimethicone cream

  • NDC Code(s): 59088-829-01, 59088-829-05, 59088-829-08, 59088-829-69
  • 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 1.75%

    Purpose

    Skin Protectant

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  • Uses

    ■ 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 cream 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, butylene glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, 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-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

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  • Daily Defense Skin Repairing Cream with GenRx Complex​TM (4 fl. oz tube label)
  • INGREDIENTS AND APPEARANCE
    GENRX DAILY DEFENSE SKIN REPAIRING 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-829
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 17.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    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-100 STEARATE (UNII: YD01N1999R)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-829-69 144 in 1 CARTON
    1 NDC:59088-829-01 4 mL in 1 POUCH
    2 NDC:59088-829-05 59 mL in 1 TUBE
    3 NDC:59088-829-08 118 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(59088-829) , pack(59088-829) , label(59088-829)
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