FDA.reportPublic FDA data

LACSIAN new perfect all care tooth

Manufacturer
Team J F&B Co., Ltd. | NEO-MEDICAL CO.,LTD
Effective date
2019-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:41

Label at a glance#

ProductLACSIAN new perfect all care tooth
Active ingredientSILICON DIOXIDE, ALCLOXA, Aminocaproic Acid
Label structure8 sections

Indications and uses

Uses: Helps protect against cavities

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

Uses: Helps protect against cavities

Directions

DOSAGE & ADMINISTRATION SECTION

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

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMINOCAPROIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809328356811GTIN-13: 8809328356811
EAN-13: 8809328356811
GTIN storage (14 digits): 08809328356811		tooth carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72048-030-022022-07-29C16284748780-1e4f33bdf-a7c3-d8a0-e053-dadaa90a6e4e0089480e-8c08-48cb-9d54-39c1eb41bb6d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72048-030-01LACSIAN new perfect all care tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
72048-030-02LACSIAN new perfect all care tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72048-030LACSIAN NEW PERFECT ALL CARE TOOTH (SILICON DIOXIDE, ALCLOXA, AMINOCAPROIC ACID) PASTE, DENTIFRICE [TEAM J F&B CO., LTD.]1Legacy NDC, 2 package rows20191127_0089480e-8c08-48cb-9d54-39c1eb41bb6d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72048-03072048-030-01, 72048-030-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCLOXA18B8O9DQA2ACTIB
Aminocaproic AcidU6F3787206ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
90347796-41a1-40ff-95c2-c6afeac11b500089480e-8c08-48cb-9d54-39c1eb41bb6d2019-11-27WarningsExact identifier
spl id: 90347796-41a1-40ff-95c2-c6afeac11b50
spl set id: 0089480e-8c08-48cb-9d54-39c1eb41bb6d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.