Label: ATO STOP SISEUNDEUSI- aloe barbadensis leaf water lotion

  • 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 November 18, 2016

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  • ACTIVE INGREDIENT

    Aloe Barbadensis Leaf Water

  • INACTIVE INGREDIENT

    glycerin, butylene glycol, etc.


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    Take a suitable amount and then gently apply it to skin. It is even greater to apply it frequently everyday to extreamely dry spots.

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ATO STOP SISEUNDEUSI 
    aloe barbadensis leaf water lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70098-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF63.52 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70098-0003-1150 g in 1 TUBE; Type 0: Not a Combination Product11/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/18/2016
    Labeler - GK COSMETIC CO., LTD. (688477309)
    Registrant - GK COSMETIC CO., LTD. (688477309)
    Establishment
    NameAddressID/FEIBusiness Operations
    GK COSMETIC CO., LTD.688477309manufacture(70098-0003) , label(70098-0003) , pack(70098-0003)