AN TOOTH

Manufacturer
AN Co Ltd.
Effective date
2017-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:56

Label at a glance#

ProductAN TOOTH
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

Directions: Brush teeth with balance of toothpaste.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Sodium Monofluorophosphate 0.01%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Precipitated Calcium Carbonate, D-Sorbitol Solution, Glycerin, Sodium Lauryl Sulfate, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Mentha Oil, l-Menthol, Methyl ρ-Hydroxybenzoate, Steviol Glycoside, Aminocaproic Acid, Xylitol, Aluminum Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrat, Chitosan, Propolis Extract, Argentum, FD&C Blue No.1, Deionized Water

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticaries

WARNINGS

WARNINGS SECTION

Warnings: 1. Try not to swallow toothpaste, gargle enough with water. 2. If a problem arises as these toothpaste, consult to dentist or physician after stop the using. 3. If use a children under six years of age, just use like pea-sized amount and supervise child’s brushing and rinsing. 4. If swallowed the toothpaste a children under six years of age, immediately consult with dentist or physician. 5. Keep this product out of the reach of children under six years of age.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this product out of the reach of children under six years of age.

Directions

INDICATIONS & USAGE SECTION

Directions: Brush teeth with balance of toothpaste.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Brush teeth with balance of toothpaste.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69153-120-022023-01-30C16284748780-1f386c649-a474-0266-e053-dadaa90a7c1a0989102a-cf0c-4ddb-9f0e-5b2c85c93ddd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69153-120-01AN TOOTH160 g in 1 TUBEPASTE, DENTIFRICE1601
69153-120-02AN TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69153-120AN TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AN CO LTD.]1Legacy NDC, 2 package rows20170227_0989102a-cf0c-4ddb-9f0e-5b2c85c93ddd.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69153-12069153-120-01, 69153-120-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
1240e625-d815-47c2-8c98-8fa297fa609b0989102a-cf0c-4ddb-9f0e-5b2c85c93ddd2017-02-27WarningsExact identifier
spl id: 1240e625-d815-47c2-8c98-8fa297fa609b
spl set id: 0989102a-cf0c-4ddb-9f0e-5b2c85c93ddd

Reported adverse events (FAERS/openFDA)#

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