LACSIAN New Perfect All Care Tooth: Package Insert and Label Information

LACSIAN NEW PERFECT ALL CARE TOOTH- silicon dioxide, alcloxa and aminocaproic acid 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.

ACTIVE INGREDIENT

Active ingredients: Silica 15.0%, Alcloxa 0.13%, Aminocaproic Acid 0.17%

INACTIVE INGREDIENT

Inactive ingredients:

Sorbitol, Water, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Mentha Piperita (Peppermint) Oil, Sodium Chloride, Hydroxyapatite, Calcium Glycerophosphate, Bentonite, Glycyrrhiza Glabra (Licorice) Root Extract, Xylitol, Sodium Saccharin, Ascorbic Acid, Protease, Tocopheryl Acetate, Gentiana Lutea Root Extract, Sophora Angustifolia Root Extract, Lavandula Angustifolia (Lavender) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Scutellaria Baicalensis Root Extract, Propolis Extract, Krameria Triandra Root Extract, Commiphora Myrrha Oil, Menthol, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Silver

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

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LACSIAN NEW PERFECT ALL CARE TOOTH
silicon dioxide, alcloxa, aminocaproic acid paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72048-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 18.0 g in 120 g
ALCLOXA (ALCLOXA) ALCLOXA 0.15 g in 120 g
Aminocaproic Acid (AMINOCAPROIC ACID) Aminocaproic Acid 0.20 g in 120 g
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72048-030-02 1 TUBE in 1 CARTON contains a TUBE (72048-030-01)
1 NDC:72048-030-01 120 g in 1 TUBE This package is contained within the CARTON (72048-030-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2019
Labeler — Team J F&B Co., Ltd. (694065040)
Registrant — Team J F&B Co., Ltd. (694065040)
Establishment
Name Address ID/FEI Operations
NEO-MEDICAL CO.,LTD 689755531 manufacture (72048-030)

Revised: 11/2019 Team J F&B Co., Ltd.

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