Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 384863bd-b2cb-a46d-e063-6394a90a3ce2
Route
TOPICAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Sorbitol Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-23

Description

Sodium Monofluorophosphate 0.74%

Purpose

Caries prevention


Medication Information

Purpose

Caries prevention

Description

Sodium Monofluorophosphate 0.74%

Uses

■ Keep your teeth white and strong.

■ Keeps the oral cavity clean.

■ Refreshes the oral cavity.

■ Prevents cavities and eliminates bad breath.

■ Enhance the aesthetic effect.

■ Prevention of gingivitis, periodontitis (pyorrhoea), periodontal disease, prevention of gum disease.

■ Remove dental plaque (anti-prag).

Section 51945-4

Section 53413-1

Questions

■ www.karlnhans.com | Customer center : 02-3451-2000

Warnings

■ Fluorine content of this product is 977ppm.

■ In the following cases, immediately stop using this product and consult a doctor or dentist.

(1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product.

(2) If a child under 6 years old swallows a large amount.

■ Other precautions when using this product.

(1) Be careful not to swallow it and rinse your mouth thoroughly after use.

(2) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Precautions for storage.

(1) Keep out of the reach of children under 6 years of age.

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient

Sodium Monofluorophosphate 0.74%

Other Information

■ Airtight container, Store in normal temperature (1~30℃)

Inactive Ingredient

Sorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Jasmine Flavor, Menthol, Stevioside, Jasmine-Mint Flavor, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract

Keep Out of Reach of Children

■ Keep out of the reach of children under 6 years of age.


Structured Label Content

Uses

■ Keep your teeth white and strong.

■ Keeps the oral cavity clean.

■ Refreshes the oral cavity.

■ Prevents cavities and eliminates bad breath.

■ Enhance the aesthetic effect.

■ Prevention of gingivitis, periodontitis (pyorrhoea), periodontal disease, prevention of gum disease.

■ Remove dental plaque (anti-prag).

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

■ www.karlnhans.com | Customer center : 02-3451-2000

Purpose (PURPOSE)

Caries prevention

Warnings (WARNINGS)

■ Fluorine content of this product is 977ppm.

■ In the following cases, immediately stop using this product and consult a doctor or dentist.

(1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product.

(2) If a child under 6 years old swallows a large amount.

■ Other precautions when using this product.

(1) Be careful not to swallow it and rinse your mouth thoroughly after use.

(2) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Precautions for storage.

(1) Keep out of the reach of children under 6 years of age.

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate 0.74%

Other Information (Other information)

■ Airtight container, Store in normal temperature (1~30℃)

Inactive Ingredient (INACTIVE INGREDIENT)

Sorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Jasmine Flavor, Menthol, Stevioside, Jasmine-Mint Flavor, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

■ Keep out of the reach of children under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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