73927-0008

73927-0008
SPL v1
SPL
SPL Set ID 3340c9cd-08fd-23da-e063-6394a90a7b9b
Route
dental
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1 g) olaflur (0.0975 g)
Inactive Ingredients
titanium sucralose mica cellulose gum propylene glycol o-cymen-5-ol malic acid chondrus crispus carrageenan sodium benzoate citrus limon (lemon) peel oil sodium chloride tetrasodium pyrophosphate sorbitol water hydrated silica glycerin peg-8 hydroxyapatite sodium lauroyl sarcosinate parfumidine xylitol ci 77891 sodium phytate menthol tin oxide

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2025-04-21

Purpose

Anticaries

Description

OLAFLUR 0.0975% SODIUM MONOFLUOROPHOSPHATE 1%


Medication Information

Warnings

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



Purpose

Anticaries



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



Description

OLAFLUR 0.0975% SODIUM MONOFLUOROPHOSPHATE 1%

Use

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



Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

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.



Do Not Use

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



Active Ingredient(s)

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Package Label Principal Display Panel


Structured Label Content

Warnings

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



Purpose

Anticaries



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 (Other information)

No

Inactive Ingredients (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



Use

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



Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.



Do Not Use (Do not use)

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



Active Ingredient(s)

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)