Label: SOOM MOUTHWASH- sodium fluoride, allantoin liquid

  • 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, 2020

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  • ACTIVE INGREDIENT

    Sodium Fluoride, allantoin

  • PURPOSE

    ■ Help teeth whitening and reduce of bad breath

    ■ Aids in the prevention of gingivitis, periodontitis

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Adults and children 6 years of age and older

    ■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out.

    ■ Do not swallow

    ■ Children under 6 years of age: do not use

  • WARNINGS

    Do not use in Children under 6 years of age

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SOOM MOUTHWASH 
    sodium fluoride, allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79717-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79717-0001-111 mL in 1 POUCH; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/24/2020
    Labeler - TECOZYME INC (694613703)
    Registrant - TECOZYME INC (694613703)
    Establishment
    NameAddressID/FEIBusiness Operations
    TECOZYME INC694613703manufacture(79717-0001)
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