BON SCENT SPARKLING TOOTH WASH- sodium fluoride tablet

BON SCENT Sparkling Tooth Wash by

Drug Labeling and Warnings

BON SCENT Sparkling Tooth Wash by is a Otc medication manufactured, distributed, or labeled by Lucella Co.,ltd, EQMAXON Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Sodium Fluoride 1.1%

INACTIVE INGREDIENT

Inactive ingredients:

DL-Malic acid, DL-Camphor, Glyceryl Monostearate, Glycyrrhizinic acid, Sodium Lauroyl Sarcosinate, Mannitol, Menthol, peppermint oil, Sodium Saccharin dihydrate, Magnesium stearate, Xylitol, Tricalcium phosphate, Calcium Carbonate, Colloid Silica, Sodium bicarbonate, PEG-150, Enzymatically Modified Stevia, Hydroxypropylmethylcellulose

PURPOSE

Purpose: Anticaries & Anticavity

WARNINGS

Warnings:

- Keep in a cool and dry place.
- Do not swallow.
- The fluorine content is 583.21ppm. (Total content should be less than 1,000ppm)
- If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately.
- Keep out of the reach of children under 6 years.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years.

Uses

Uses:
Helps protect against cavities

Directions

Directions:
- Put 1 tablet into your mouth and wash your gums, teeth, and tongue using your tongue and lips.
-Lastly rinse several times with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BON SCENT SPARKLING TOOTH WASH 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72869-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9.38 mg  in 853 mg

Inactive Ingredients
Ingredient Name	Strength
Mannitol (UNII: 3OWL53L36A)
Menthol (UNII: L7T10EIP3A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72869-010-02	30 in 1 POUCH	01/02/2019
1	NDC: 72869-010-01	853 mg in 1 BLISTER PACK; 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	01/02/2019

Labeler - Lucella Co.,ltd (694733285)

Registrant - Lucella Co.,ltd (694733285)

Establishment
Name	Address	ID/FEI	Business Operations
EQMAXON Corp.		557821534	manufacture(72869-010)