Label: BUBISON GOLD GEL (ETHANOL) COMPLETE HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 22, 2020

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  • ACTIVE INGREDIENT

    ethanol

  • INACTIVE INGREDIENT

    Purifiedwater, butyleneglycol, carbomer, licoriceextract, glycerin, aloevera gel, greenteaextract, sodiumhyaluronate (2), fragrance, triethanolamine

  • PURPOSE

    Hand wash for disinfection and bacteria removal

  • WARNINGS

    ■ if following abnormal symptoms persist, discontinue use

    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    ■ Stop immediately and consult a doctor if you experience

    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

    2) Skin Irritation

    3) Following Instructions when using medication

    (1) For external use only (Do not use internally)

    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

    ■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

    ■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

    It is not recommended to use this one areas that have been medically treated with a cast or bandage.

    ■ Do not use in combination with soap or antibacterial cleansing agents.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep Out of Reach of Children.

  • INDICATIONS & USAGE

    ■ Pour a small amount into hands, spread evenly and rub into the skin

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BUBISON GOLD GEL (ETHANOL) COMPLETE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59405-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    LICORICE (UNII: 61ZBX54883)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59405-0001-3300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
    2NDC:59405-0001-250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
    3NDC:59405-0001-12 mL in 1 POUCH; Type 0: Not a Combination Product04/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/04/2020
    Labeler - Seoul cosmetics co ltd (688397660)
    Registrant - Seoul cosmetics co ltd (688397660)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seoul cosmetics co ltd688397660manufacture(59405-0001)
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