Label: S.COLINE- hydrogenated soybean liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 5, 2015

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  • ACTIVE INGREDIENT

    soybean oil


  • INACTIVE INGREDIENT

    charcoal powder, turmeric extract, rice bran, mugwort extract, red yeast extract, ethanol, wheat flour, mung bean extract, saccharin, etc


  • PURPOSE

    lipolytic
    hyperlipidemia elimination
    skin elasticity recovery


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply to skin and massage
    Wait for about 1 hour
    Wash away with clean water.


  • WARNINGS

    do not swallow
    do not use if you have skin wounds
    do not use if you have allergies


  • DOSAGE & ADMINISTRATION

    for topical use  only

  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    S.COLINE 
    hydrogenated soybean liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61164-6001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) (HYDROGENATED SOYBEAN OIL - UNII:A2M91M918C) HYDROGENATED SOYBEAN OIL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CITRUS MAXIMA FRUIT OIL (UNII: RE84WIN5OB)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61164-6001-1250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357C01/02/2015
    Labeler - Barona Co., Ltd (688735111)
    Registrant - Barona Co., Ltd (688735111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Barona Co., Ltd 688735111manufacture(61164-6001)
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