Label: CHEON SHIM BO HWA- borage oil capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 6, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: Borage oil, D Alpha Tocopherol
  • INACTIVE INGREDIENT

    Inactive ingredient: fish oil, mandarin orange peel extract powder, palm oil, yellow wax, red ginseng extract powder, soy lecithin, green tea extract, soybean extract, quercetin powder, gelatin, glycerin, D-sorbitol, cochineal, titanium dioxide
  • DOSAGE & ADMINISTRATION

    1 day 4 tablets, 1 time 2 tablets
  • INDICATIONS & USAGE

    necessary to protect cells from free radicals
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children
  • PURPOSE

    helps maintain healthy chlesterol and blood circulation
  • WARNINGS

    patients with a history of idiosyncrasy and allergy may have a higher risk of a hypersensitivity
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    CHEON SHIM BO HWA 
    borage oil capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51220-5001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORAGE OIL (UNII: F8XAG1755S) (BORAGE OIL - UNII:F8XAG1755S) BORAGE OIL311 mg
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL ACETATE, D- - UNII:A7E6112E4N) .ALPHA.-TOCOPHEROL ACETATE, D-1 mg
    Inactive Ingredients
    Ingredient NameStrength
    FISH OIL (UNII: XGF7L72M0F)  
    MANDARIN OIL (UNII: NJO720F72R)  
    PALM OIL (UNII: 5QUO05548Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    QUERCETIN (UNII: 9IKM0I5T1E)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    Product Characteristics
    Colorred (dark red) Scoreno score
    ShapeOVAL (none) Size10mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51220-5001-1112 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/06/2011
    Labeler - Saimdang Cosmetics Co., Ltd (689191286)
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