Label: ELGOALIN HISENG- mineral oil liquid

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

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Drug Label Information

Updated April 17, 2022

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  • ACTIVE INGREDIENT

    mineral oil, petrolatum

  • INACTIVE INGREDIENT

    aloe barbadensis leaf extract, matricaria flower extract, sunflower seed oil, glycerin, butlyne glycol

  • PURPOSE

    ■ temporarily protects irritated areas ■ temporarily relieves burning ■ temporarily protects inflamed anorectal skin ■ temporarily relieves the symptoms of anorectal skin irritation

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ spray liverally to the affected area as necessary

  • WARNINGS

    For external use only

    When using this product

    ■ do not exceed the recommended daily dosage unless directly by a doctor

    ■ do not put into the rectum by using fingers or any mechanical device or applicator ■ avoid contact with eyes ■ rinse with water to remove ■ do not swallow ■ do not store at temperature above 120 degree F

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ELGOALIN HISENG 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82677-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM35 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL55 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82677-0001-150 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/18/2022
    Labeler - Elgoalin Bio Co.,Ltd (688353068)
    Registrant - Elgoalin Bio Co.,Ltd (688353068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elgoalin Bio Co.,Ltd688353068manufacture(82677-0001)
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