Label: ATONO2 OXYGEN BABY- betaine 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 October 13, 2016

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  • ACTIVE INGREDIENT

    Betaine

  • INACTIVE INGREDIENT

    Water, Glycerin, Centella Asiatica Extract, Portulaca Oleracea Extract, etc.

  • PURPOSE

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply proper amount to the skin

  • WARNINGS

    • For external use only
    • When using this product

    1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.
    A. red spot, swelling, itching, stimulus
    B. symptoms mentioned above are caused by sunlight.

    2. Do not apply on skin where there is wound, eczema, or irritation.

    3. Storage and cautions for handling
    A. Close stopper after using.
    B. Keep out of reach of children.
    C. Keep away from high or low temperature and direct sunlight.

    4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    l

  • INGREDIENTS AND APPEARANCE
    ATONO2 OXYGEN BABY 
    betaine lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70993-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70993-0005-1160 g in 1 TUBE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2015
    Labeler - LAORGANIC Co., Ltd. (689844148)
    Registrant - LAORGANIC Co., Ltd. (689844148)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAORGANIC Co., Ltd.689844148manufacture(70993-0005)