PURE MOUTH LIQUID- sodium fluoride liquid

Pure Mouth Liquid by

Drug Labeling and Warnings

Pure Mouth Liquid by is a Otc medication manufactured, distributed, or labeled by On On Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

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

PURPOSE

Remove bad breath, prevent tooth decay

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

for oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE MOUTH LIQUID 
sodium fluoride liquid

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

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
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

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

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

Labeler - On On Co., Ltd. (695015695)

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

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