Label: SOOM MOUTHWASH- sodium fluoride 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 June 10, 2020

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  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    Water
    Sodium Fluoride
    Allantoin
    Erythritol
    xylitol
    Sodium benzoate
    Glycerin
    Propylene Glycol
    PEG-40 Hydrogenated Castor Oil
    L-Menthol
    zinc gluconate
    sodium citrate
    Fragrance

  • PURPOSE

    prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing

  • WARNINGS

    For oral use only.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

  • DOSAGE & ADMINISTRATION

    for oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SOOM MOUTHWASH 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73927-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    ERYTHRITOL (UNII: RA96B954X6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73927-0005-111 mL in 1 POUCH; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/10/2020
    Labeler - BD TECHNOLOGY CO., LTD (695005161)
    Registrant - BD TECHNOLOGY CO., LTD (695005161)
    Establishment
    NameAddressID/FEIBusiness Operations
    BD TECHNOLOGY CO., LTD.695005161manufacture(73927-0005) , label(73927-0005)
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