SPL v4
SPL
SPL Set ID 93113481-ad9d-4be0-a7b7-a72c8726127d
Route
ORAL
Published
Effective Date 2025-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.72 g)
Inactive Ingredients
Calcium Carbonate Dibasic Calcium Phosphate Dihydrate Aluminum Chlorohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Sodium Monofluorophosphate 0.72%

Purpose

Caries prevention


Medication Information

Purpose

Caries prevention

Description

Sodium Monofluorophosphate 0.72%

Uses

■ Keep your teeth white and strong.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of gingivitis and periodontitis (alveolar fistula)

■ Prevention of periodontal disease

■ Prevention of gum disease

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Warnings

■ Contains 950ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use,

discontinue use and consult your doctor.

■ 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.

■ Consult a physician or dentist immediately if a child under 6 years old has

swallowed large quantities.

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

Questions

02-515-0529

www.rorobell.com

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient

Sodium Monofluorophosphate 0.72%

Other Information

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

Inactive Ingredients

Calcium Carbonate, Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Thyme Flavor, Dicalcium Phosphate Dihydrate, Xylitol, Erythritol, Mentha Piperita Oil, Hydroxyapatite, Alcloxa, Sodium Copper Chlorophyllin, Glycyrrhiza Uralensis Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Taraxacum Officinale Extract, Allyl Isothiocyanate, Pistacia Lentiscus Gum Oil

Package Label (tube)

Package Label (carton)

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.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of gingivitis and periodontitis (alveolar fistula)

■ Prevention of periodontal disease

■ Prevention of gum disease

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Purpose (PURPOSE)

Caries prevention

Warnings (WARNINGS)

■ Contains 950ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use,

discontinue use and consult your doctor.

■ 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.

■ Consult a physician or dentist immediately if a child under 6 years old has

swallowed large quantities.

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

Questions (QUESTIONS)

02-515-0529

www.rorobell.com

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate 0.72%

Other Information

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Calcium Carbonate, Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Thyme Flavor, Dicalcium Phosphate Dihydrate, Xylitol, Erythritol, Mentha Piperita Oil, Hydroxyapatite, Alcloxa, Sodium Copper Chlorophyllin, Glycyrrhiza Uralensis Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Taraxacum Officinale Extract, Allyl Isothiocyanate, Pistacia Lentiscus Gum Oil

Package Label (tube) (PACKAGE LABEL (Tube))

Package Label (carton) (PACKAGE LABEL (Carton))

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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