SOOM GREEN MOUTHWASH- sodium fluoride liquid 
TECOZYME INC

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.

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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

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)

Revised: 8/2021
Document Id: a4653787-ec8b-4a73-a52a-c978cb318420
Set id: e1d973c2-ef96-4da5-abd2-6f4a30224850
Version: 1
Effective Time: 20210817
 
TECOZYME INC