Label: CHEON SHIM BO HWA- borage oil capsule

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)