SOOM GREEN MOUTHWASH- sodium fluoride liquid

Soom Green Mouthwash by

Drug Labeling and Warnings

Soom Green Mouthwash by is a Otc medication manufactured, distributed, or labeled by TECOZYME INC, BD TECH CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOOM GREEN MOUTHWASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79717-0010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Erythritol (UNII: RA96B954X6)
Xylitol (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79717-0010-2	20 in 1 CARTON	08/01/2021
1	NDC: 79717-0010-1	11 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2021

Labeler - TECOZYME INC (694613703)

Registrant - TECOZYME INC (694613703)

Establishment
Name	Address	ID/FEI	Business Operations
BD TECH CO LTD		695005161	manufacture(79717-0010)