Label: ATONO2 OXYGEN BABY SOOTHING GEL- glycerin gel

  • Category: HUMAN OTC DRUG LABEL

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 October 13, 2016

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  • ACTIVE INGREDIENT

    Glycerin

  • INACTIVE INGREDIENT

    Panthenol, Betaine, Allantoin, Beta-Glucan, Sodium Hyaluronate, 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 SOOTHING GEL 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70993-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN11.985 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BETAINE (UNII: 3SCV180C9W)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70993-0010-1160 g in 1 TUBE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/01/2015
    Labeler - LAORGANIC Co., Ltd. (689844148)
    Registrant - LAORGANIC Co., Ltd. (689844148)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAORGANIC Co., Ltd.689844148manufacture(70993-0010)
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