Label: ATOBOS BABY AQUA SOOTHING- allantoin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 24, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.5%

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Centella Asiatica Extract, Glycerin, Butylene Glycol, Water, Panthenol, Betaine, Carbomer, Arginine, Caprylyl Glycol, Glyceryl Polyacrylate, Dipotassium Glycyrrhizate, Caprylhydroxamic Acid, Azadirachta Indica Leaf Extract, Olea Europaea (Olive) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Artemisia Annua Extract, Taraxacum Officinale (Dandelion) Leaf Extract, Symphytum Officinale Leaf Extract, Helichrysum Arenarium Flower Extract, Calendula Officinalis Flower Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Pulsatilla Koreana Extract, Zanthoxylum Piperitum Fruit Extract, Usnea Barbata (Lichen) Extract

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions. A. Close the lid after use. B. Do not store in high- temperature or low- temperature and keep away from direct sunlight. 4. Wash off the product if it gets in the eye.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INDICATIONS & USAGE

    Indications & Usage: After washing the face & body, dispense an appropriate amount into your palm, and evenly apply to the entire face and body.

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  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ATOBOS BABY AQUA SOOTHING 
    allantoin gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-070
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.8 mg  in 160 mL
    Inactive Ingredients
    Ingredient Name Strength
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69739-070-01 160 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/01/2015
    Labeler - 1004LABORATORY (689512629)
    Registrant - 1004LABORATORY (689512629)
    Establishment
    Name Address ID/FEI Business Operations
    1004LABORATORY 689512629 manufacture(69739-070)
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