Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 38487130-9508-a2c4-e063-6394a90aa323
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 2025-06-01

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

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.

Questions

Questions

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

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, Double-Mint Flavor, Cellulose Gum, Menthol, Stevioside, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Camellia Sinensis Leaf Extract, Aloe Barbadensis 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)

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.

Questions

Questions

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

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, Double-Mint Flavor, Cellulose Gum, Menthol, Stevioside, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Camellia Sinensis Leaf Extract, Aloe Barbadensis 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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