LACSISN perfect sensitive by Team J F&B Co., Ltd. / NEO-MEDICAL CO.,LTD

LACSISN perfect sensitive by

Drug Labeling and Warnings

LACSISN perfect sensitive by is a Otc medication manufactured, distributed, or labeled by Team J F&B Co., Ltd., NEO-MEDICAL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LACSISN PERFECT SENSITIVE- tricalcium phosphate, silicon dioxide paste, dentifrice 
Team J F&B Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active ingredients: TRICALCIUM PHOSPHATE 19%, SILICON DIOXIDE 2.5%

INACTIVE INGREDIENT

Inactive ingredients:

D-Sorbitol Solution, Purified Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Sophora Extract, Peppermint Oil,

Xylitol, L-Menthol, Sodium Saccharin, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Sodium Chloride,

Camomille Extract, Lavender Extract, Gentiana Extract, Propolis Extract, Sage Extract, Hydroxyapatite, Tocopheryl Acetate,

Bentonite, Myrrh Tincture, Rhatany Tincture, Mastic Oil

PURPOSE

Purpose: Anticavity

WARNINGS

Warnings: Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

Uses: Helps protect against cavities

Directions

Directions:

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LACSISN PERFECT SENSITIVE 
tricalcium phosphate, silicon dioxide paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72048-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	22.8 g  in 120 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	3.0 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72048-020-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 72048-020-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2018	11/01/2019

Labeler - Team J F&B Co., Ltd. (694065040)

Registrant - Team J F&B Co., Ltd. (694065040)

Establishment
Name	Address	ID/FEI	Business Operations
NEO-MEDICAL CO.,LTD		689755531	manufacture(72048-020)

Revised: 11/2019

Document Id: bc134efe-6248-4c00-bee1-54471901afe1

34390-5

Set id: d53db7e7-03d4-49e5-9764-729040ddf7ae

Version: 2

Effective Time: 20191127

 

Team J F&B Co., Ltd.