Label: GYNOX-SOFT- boric acid emulsion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 7, 2012

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  • ACTIVE INGREDIENT

    GYNOX-SOFT is a foaming emulsion with Boric acid that is a antiseptic agent to control the microbial load present in the intimate area.

  • PURPOSE

    GYNOX SOFT NEUTRAL, SCENTED OR TEEN,  bubble bath is an antibacterial action, cleaning, fungicidal, and antibacterial that can be used by the whole family, including new borns.

  • KEEP OUT OF REACH OF CHILDREN

    This product must be out of reach of children

  • INDICATIONS & USAGE

    GYNOX-SOFT is intimate hygiene foaming emulsion and body for men, women and teenagers of antibacterial action. Is pH balanced, is in daily use before, during and after the menstrual cycle, deep asepsis of hands skin complaints and scalp.

  • WARNINGS

    Suspend its use if you observed any desfavorable reaction. This product may be irritate your skin if you do not follow the recommended instructions. Contact with eyes may produce irritation and burning sensation; if this occurs flush your eyes immediately with fresh water.

  • DOSAGE & ADMINISTRATION

    This product is for topical application. Add in the application area amount of product, rub gently to obtain foam and rinse.

  • INACTIVE INGREDIENT

    This product is an emulsion, made with ingredients that provide moisturization, and protection in the intimate area. Is non toxic and has no known contraindications.

  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    GYNOX-SOFT 
    boric acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID7 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorwhite (BEIGE) , pink (PINK) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-003-01210 mL in 1 BOTTLE
    2NDC:66854-003-02250 mL in 1 BOTTLE
    3NDC:66854-003-03260 mL in 1 BOTTLE
    4NDC:66854-003-04270 mL in 1 BOTTLE
    5NDC:66854-003-05400 mL in 1 BOTTLE
    6NDC:66854-003-06515 mL in 1 BOTTLE
    7NDC:66854-003-071000 mL in 1 BOTTLE
    8NDC:66854-003-0930 in 1 BOX
    8NDC:66854-003-0812 mL in 1 BAG
    9NDC:66854-003-10500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack
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