73927-0009

73927-0009
SPL v1
SPL
SPL Set ID 3341ef2d-7fa5-b828-e063-6394a90ab191
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
Sodium Benzoate Tetrasodium Pyrophosphate Malic Acid Xylitol Chondrus Crispus Carrageenan Sucralose Cellulose Gum Sodium Chloride Ci 16255 Sorbitol Water Hydrated Silica Peg-8 Glycerin Sodium Lauroyl Sarcosinate Flavor Spice Mint N&a110589 Sodium Phytate Chromite Propylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-21

Description

OLAFLUR 0.0975% SODIUM MONOFLUOROPHOSPHATE 1%

Purpose

Anticaries


Medication Information

Purpose

Anticaries



Description

OLAFLUR 0.0975% SODIUM MONOFLUOROPHOSPHATE 1%

Use

15%Fine Salt Ampoule Toothpaste can effectively and gently cleans teeth and mouth, 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 waterIf there

Section 50567-7

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.



Warnings

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



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.)



Do Not Use

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



Other Information

No

Active Ingredient(s)

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Inactive Ingredients

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


Structured Label Content

Use

15%Fine Salt Ampoule Toothpaste can effectively and gently cleans teeth and mouth, 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 waterIf there

Section 50567-7 (50567-7)

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.



Purpose

Anticaries



Warnings

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



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.)



Do Not Use (Do not use)

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



Other Information (Other information)

No

Active Ingredient(s)

OLAFLUR 0.0975%

SODIUM MONOFLUOROPHOSPHATE 1%

Inactive Ingredients (Inactive ingredients)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)