FDA.reportPublic FDA data

Nobaton 1.5%Fine Salt ampoule

Manufacturer
BD TECHNOLOGY CO.,LTD
Effective date
2025-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:27

Label at a glance#

ProductNobaton 1.5%Fine Salt ampoule
Active ingredientSODIUM MONOFLUOROPHOSPHATE, OLAFLUR
Label structure12 sections

Dosage and administration

Squeeze an appropriate amount of toothpaste onto the toothbrush, and brush teeth from the inside to the outside using an up and down rubbing motion. Rinse mouth after 3 minutes. (It is recommended to brush without water.)

Storage and handling

No

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Purpose

OTC - PURPOSE SECTION

Anticaries

Use

INDICATIONS & USAGE SECTION

15%Fine Salt Ampoule Toothpaste can effectively and gently cleans teeth and mouth, and resist dental caries.

Warnings

WARNINGS SECTION

Do not swallow; Suitable for adults: Store in a cool and dry place.

Do not use

OTC - DO NOT USE SECTION

in children less than 12 years old; People with dental fluorosis

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with waterIf there is
any discomfort, please stop using and consult a doctor. Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

In case of contact with eyes, rinse eyes thoroughly with waterIf there

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Squeeze an appropriate amount of toothpaste onto the toothbrush, and brush teeth from the inside to the outside
using an up and down rubbing motion. Rinse mouth after 3 minutes. (It is recommended to brush without water.)

Other information

STORAGE AND HANDLING SECTION

No

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Glycerin, PEG-8, Sodium Lauroyl Sarcosinate, Mineral Salts, Flavor, Cellulose Gum,
Sodium Benzoate, Tetrasodium Pyrophosphate, Xylitol Sodium Phytate, Malic Acid, Sucralose, Chondrus Crispus
Extract, Propylene Glycol, Sodium Chloride, CI 16255

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

undefinedundefined

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73927-0009-1Nobaton 1.5%Fine Salt ampoule35 g in 1 TUBEOINTMENT351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73927-0009NOBATON 1.5%FINE SALT AMPOULE (NOBATON 1.5%FINE SALT AMPOULE TOOTHPASTE) OINTMENT [BD TECHNOLOGY CO.,LTD]11 package rows20250423_3341ef2d-7fa5-b828-e063-6394a90ab191.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73927-000973927-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
MALIC ACID817L1N4CKPIACT
XYLITOLVCQ006KQ1EIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
SUCRALOSE96K6UQ3ZD4IACT
CELLULOSE GUMK679OBS311IACT
SODIUM CHLORIDE451W47IQ8XIACT
CI 16255Z525CBK9PGIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
PEG-8B697894SGQIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
SODIUM PHYTATE88496G1ERLIACT
OLAFLUR8NY9L8837DACTIB
CHROMITEW86U2Q2334IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
3341ef39-b2cf-a9a3-e063-6294a90ab2233341ef2d-7fa5-b828-e063-6394a90ab1912025-04-20WarningsExact identifier
spl id: 3341ef39-b2cf-a9a3-e063-6294a90ab223
spl set id: 3341ef2d-7fa5-b828-e063-6394a90ab191

Reported adverse events (FAERS/openFDA)#

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