Label: O2 BUBBLE PACK WASH- dimethicone liquid

  • 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 December 10, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients: Dimethicone 1%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water,Sodium Laureth Sulfate,Cocamidopropyl,Betaine,Disodium Cocoamphodipropionate,PEG-7 Glyceryl Cocoate,Acrylates Copolymer,Acrylates/Beheneth-25 Methacrylate Copolymer,Methyl Perfluorobutyl Ether,Methyl Perfluoroisobutyl Ether,Polyhydroxystearic Acid,Ethylhexyl Isononanoate,Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate,Isononyl Isononanoate,Snail Secretion Filtrate, Glycerin,Psidium Guajava Fruit Extract,Litchi Chinensis Fruit Extract,Mangifera Indica (Mango) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract,Nephelium Lappaceum Extract,Carica Papaya (Papaya) Fruit Extract,Fragrance,Potassium Alum,Pearl Powder,Xanthan Gum,Potassium Hydroxide,Trisodium EDTA, Papain,Methylchloroisothiazolinone,Methylisothiazolinone

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warning:
    1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. you are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children: Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indication and Usage: After cleansing, pump three times and roll on the dry face avoiding eye area. Rinse off with lukewarm water after 5 minutes.

  • DOSAGE AND ADMINISTRATION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    O2 BUBBLE PACK WASH 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69072-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Betaine (UNII: 3SCV180C9W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69072-030-01100 mL in 1 CARTON; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2014
    Labeler - Seindni Co.,ltd (557837682)
    Registrant - Seindni Co.,ltd (557837682)
    Establishment
    NameAddressID/FEIBusiness Operations
    PICOSTECH Co.,Ltd.557816754manufacture(69072-030)