FDA.reportPublic FDA data

Nobaton 1% Alpha Hydroxy Acid 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% Alpha Hydroxy Acid 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

l% Alpha Hydroxy Acid Ampoule Toothpaste can deeply clean the mouth and teeth, 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 chilren 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 water. If 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 water.

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

SorbitolWater,Hydrated Silica,Glycerin,Peg-8,Hydroxyapatite,Sodium Lauroyl Sarcosinate,Parfum,Sodium Phytate,
Cellulose Gum,Sodium Benzoate,Tetrasodium Pyrophosphate,Xyltol,Ci 77891Malic Acid,Sucralose,Menthol,
Chondrus Crispus Extract,Propylene GlycolMica,o-Cymen-5-OlTitanium Dioxide,Citrus Limon (Lemon) Peel Oil,
Sodium Chloride,Tin Oxide

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
73927-0008-1Nobaton 1% Alpha Hydroxy Acid Ampoule35 g in 1 TUBEOINTMENT351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73927-0008NOBATON 1% ALPHA HYDROXY ACID AMPOULE (NOBATON 1% ALPHA HYDROXY ACID AMPOULE TOOTHPASTE) OINTMENT [BD TECHNOLOGY CO.,LTD]11 package rows20250423_3340c9cd-08fd-23da-e063-6394a90a7b9b.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73927-000873927-0008-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUMD1JT611TNEIACT
SUCRALOSE96K6UQ3ZD4IACT
MICAV8A1AW0880IACT
CELLULOSE GUMK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
O-CYMEN-5-OLH41B6Q1I9LIACT
MALIC ACID817L1N4CKPIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRUS LIMON (LEMON) PEEL OILI9GRO824LLIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SODIUM CHLORIDE451W47IQ8XIACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
PEG-8B697894SGQIACT
HYDROXYAPATITE91D9GV0Z28IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PARFUMIDINEA2Q2LHC6MAIACT
OLAFLUR8NY9L8837DACTIB
XYLITOLVCQ006KQ1EIACT
CI 7789115FIX9V2JPIACT
SODIUM PHYTATE88496G1ERLIACT
MENTHOLL7T10EIP3AIACT
TIN OXIDEKM7N50LOS6IACT

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
3340d240-a5c8-f693-e063-6294a90a880b3340c9cd-08fd-23da-e063-6394a90a7b9b2025-04-20WarningsExact identifier
spl id: 3340d240-a5c8-f693-e063-6294a90a880b
spl set id: 3340c9cd-08fd-23da-e063-6394a90a7b9b

Reported adverse events (FAERS/openFDA)#

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