NOBATON 1% ALPHA HYDROXY ACID AMPOULE- nobaton 1% alpha hydroxy acid ampoule toothpaste ointment

Nobaton 1% Alpha Hydroxy Acid Ampoule by

Drug Labeling and Warnings

Nobaton 1% Alpha Hydroxy Acid Ampoule by is a Otc medication manufactured, distributed, or labeled by BD TECHNOLOGY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Purpose

Anticaries

Use

l% Alpha Hydroxy Acid Ampoule Toothpaste can deeply clean the mouth and teeth, and resist dental caries.

Warnings

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

Do not use

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

WHEN USING

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.

STOP USE

In case of contact with eyes, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

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

No

Inactive ingredients

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

INGREDIENTS AND APPEARANCE

NOBATON 1% ALPHA HYDROXY ACID AMPOULE 
nobaton 1% alpha hydroxy acid ampoule toothpaste ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73927-0008
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 g  in 100 g
OLAFLUR (UNII: 8NY9L8837D) (OLAFLUR - UNII:8NY9L8837D)	OLAFLUR	0.0975 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM (UNII: D1JT611TNE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MICA (UNII: V8A1AW0880)
CELLULOSE GUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
MALIC ACID (UNII: 817L1N4CKP)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 (UNII: B697894SGQ)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PARFUMIDINE (UNII: A2Q2LHC6MA)
XYLITOL (UNII: VCQ006KQ1E)
CI 77891 (UNII: 15FIX9V2JP)
SODIUM PHYTATE (UNII: 88496G1ERL)
MENTHOL (UNII: L7T10EIP3A)
TIN OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73927-0008-1	35 g in 1 TUBE; Type 0: Not a Combination Product	04/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/21/2025

Labeler - BD TECHNOLOGY CO.,LTD (695005161)

Establishment
Name	Address	ID/FEI	Business Operations
BD TECHNOLOGY CO.,LTD		695005161	manufacture(73927-0008)