Label: SOOM GREEN MOUTHWASH- sodium fluoride 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 August 17, 2021

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  • ACTIVE INGREDIENT

    Sodium Fluoride 0.02%

  • PURPOSE

    Anticavity

  • Uses

    ■ Help teeth whitening and reduce of bad breath
    ■ Aids in the prevention of gingivitis, periodontitis

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • Directions

    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

  • Other Information

    ■ Read the directions and warnings before use
    ■ Store at room temperature
    ■ This rinse is not intended to replace brushing or flossing

  • QUESTIONS

    ■ www.tecozyme.com or contact@tecozyme.com

  • INACTIVE INGREDIENTS

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SOOM GREEN MOUTHWASH 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79717-0010
    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
    Water (UNII: 059QF0KO0R)  
    Erythritol (UNII: RA96B954X6)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79717-0010-220 in 1 CARTON08/01/2021
    1NDC:79717-0010-111 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/01/2021
    Labeler - TECOZYME INC (694613703)
    Registrant - TECOZYME INC (694613703)
    Establishment
    NameAddressID/FEIBusiness Operations
    BD TECH CO LTD695005161manufacture(79717-0010)
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