BON SCENT SPARKLING TOOTH WASH- sodium fluoride tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Lucella Co.,ltd
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Anticaries & Anticavity Uses: Helps protect against cavities
Authorization status:
OTC monograph final
Authorization number:
72869-010-01, 72869-010-02

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.

----------

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.

Us es

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

BON SCENT SPARKLING TOOTH WASH

sodium fluoride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 6 9 -0 10

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

So dium Fluo ride (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

9 .38 mg in 8 53 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Ma nnito l (UNII: 3OWL53L36 A)

Mentho l (UNII: L7T10 EIP3A)

Product Characteristics

Color

white

S core

no sco re

Lucella Co.,ltd

Color

S core

S hap e

ROUND

S iz e

12mm

Flavor

PEPPERMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:728 6 9 -0 10 -

30 in 1 POUCH

0 1/0 2/20 19

1

NDC:728 6 9 -0 10 -

8 53 mg in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 1/0 2/20 19

Labeler -

Lucella Co.,ltd (694733285)

Registrant -

Lucella Co.,ltd (694733285)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EQMAXON Co rp.

5578 21534

ma nufa c ture (728 6 9 -0 10 )

Revised: 4/2019

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