SOOM MOUTHWASH- sodium fluoride liquid

Soom Mouthwash by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

Water
Sodium Fluoride
Allantoin
Erythritol
xylitol
Sodium benzoate
Glycerin
Propylene Glycol
PEG-40 Hydrogenated Castor Oil
L-Menthol
zinc gluconate
sodium citrate
Fragrance

PURPOSE

prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing

WARNINGS

For oral use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

DOSAGE & ADMINISTRATION

for oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOM MOUTHWASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73927-0005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
ERYTHRITOL (UNII: RA96B954X6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73927-0005-1	11 mL in 1 POUCH; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/10/2020

Labeler - BD TECHNOLOGY CO., LTD (695005161)

Registrant - BD TECHNOLOGY CO., LTD (695005161)

Establishment
Name	Address	ID/FEI	Business Operations
BD TECHNOLOGY CO., LTD.		695005161	manufacture(73927-0005) , label(73927-0005)