Drug Facts

PURE MOUTH LIQUID- sodium fluoride liquid
On On Co., Ltd.

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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Drug Facts

sodium fluoride

Sodium fluoride
Sodium saccharin
DL-Alanine
Citric acid
Sodium citrate
Xylitol
Green extract
Licorice extract
Mugwort extract
Ginger Tincture
Sodium benzoate
l-menthol
Spearmint flavor
Purified water

Remove bad breath, prevent tooth decay

keep out of reach of the children

Use twice a day (morning and evening), use 10-15ml for one time,
take your mouth for about 30 seconds Rinse and spit out

Keep the prescribed usage, capacity.
When using in children, please use under the guidance and supervision of the guardian.
Use only for mouthwash, do not use for internal use, guitar)
Do not use for children under 6 years old unless directed by a pharmacist or doctor.

for oral use only

label

PURE MOUTH LIQUID
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72875-0001
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72875-0001-1	11 mL in 1 POUCH; Type 0: Not a Combination Product	02/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/10/2019

Labeler - On On Co., Ltd. (695015695)

Registrant - On On Co., Ltd. (695015695)

Name	Address	ID/FEI	Business Operations
Establishment
On On Co., Ltd.		695015695	label(72875-0001) , manufacture(72875-0001)