SOOM MOUTHWASH- sodium fluoride, allantoin liquid

Soom Mouthwash by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOOM MOUTHWASH 
sodium fluoride, allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79717-0001
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
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79717-0001-1	11 mL in 1 POUCH; Type 0: Not a Combination Product	07/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/24/2020

Labeler - TECOZYME INC (694613703)

Registrant - TECOZYME INC (694613703)

Establishment
Name	Address	ID/FEI	Business Operations
TECOZYME INC		694613703	manufacture(79717-0001)