BON SCENT SPARKLING TOOTH WASH- sodium fluoride tablet 
Lucella 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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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

Image of pouch

BON SCENT SPARKLING TOOTH WASH 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72869-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION9.38 mg  in 853 mg
Inactive Ingredients
Ingredient NameStrength
Mannitol (UNII: 3OWL53L36A)  
Menthol (UNII: L7T10EIP3A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72869-010-0230 in 1 POUCH01/02/2019
1NDC:72869-010-01853 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/02/2019
Labeler - Lucella Co.,ltd (694733285)
Registrant - Lucella Co.,ltd (694733285)
Establishment
NameAddressID/FEIBusiness Operations
EQMAXON Corp.557821534manufacture(72869-010)

Revised: 4/2019
Document Id: d95e5a00-3461-47a5-ab94-ae8f33864e65
Set id: a8a409c7-a3c2-49c0-91df-052f2a7a08b3
Version: 2
Effective Time: 20190417
 
Lucella Co.,ltd