4d1fca5a-d01d-4362-abd8-ffdff1275bfd

SPL v3
SPL
SPL Set ID 4d1fca5a-d01d-4362-abd8-ffdff1275bfd
Route
dental
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.05 g)
Inactive Ingredients
sodium benzoate glycerin

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2023-02-01

Purpose

Anticavity mouthwash

Description

Cetylpyridinium Chloride 0.05%


Medication Information

Warnings

■ Stop using this product and consult a dentist if irritation or discomfort occurs.

■ For children under 6 years of age, use only a small amount of toothpaste under adult supervision to prevent sucking or swallowing.

■ If a child under 6 swallows a large amount of toothpaste, seek immediate medical attention or consult a dentist.

■ Keep this product out of the reach of children under 6 years of age

Uses

■ Aids in prevention of dental cavities

Purpose

Anticavity mouthwash

Directions

■ Rinse mouth with this COOLSENSE STICK GARGLE 10ml for 60 seconds then expel

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients

Sodium benzoate, Concentrated Glycerin, Disodium EDTA, Polyoxyethylene hydrogenated caster oil, Citric acid, Trisodium Citrate dehydrate, Xylitol, Enzymatically Modified Stevia, Rosemary extract, Calendula flower extract, Aloe extract(09), Salvia (Sage) extract, Eucalyptus Globulus Leaf extract, L-menthol, Peppermint Oil, Lemon Oil, Poloxamer 407, Purified water

Description

Cetylpyridinium Chloride 0.05%

Section 51945-4

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Active Ingredient

Cetylpyridinium Chloride 0.05%

Keep Out of Reach of Children

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


Structured Label Content

Warnings (WARNINGS)

■ Stop using this product and consult a dentist if irritation or discomfort occurs.

■ For children under 6 years of age, use only a small amount of toothpaste under adult supervision to prevent sucking or swallowing.

■ If a child under 6 swallows a large amount of toothpaste, seek immediate medical attention or consult a dentist.

■ Keep this product out of the reach of children under 6 years of age

Uses

■ Aids in prevention of dental cavities

Purpose (PURPOSE)

Anticavity mouthwash

Directions

■ Rinse mouth with this COOLSENSE STICK GARGLE 10ml for 60 seconds then expel

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients (Inactive ingredients)

Sodium benzoate, Concentrated Glycerin, Disodium EDTA, Polyoxyethylene hydrogenated caster oil, Citric acid, Trisodium Citrate dehydrate, Xylitol, Enzymatically Modified Stevia, Rosemary extract, Calendula flower extract, Aloe extract(09), Salvia (Sage) extract, Eucalyptus Globulus Leaf extract, L-menthol, Peppermint Oil, Lemon Oil, Poloxamer 407, Purified water

Section 51945-4 (51945-4)

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Active Ingredient (ACTIVE INGREDIENT)

Cetylpyridinium Chloride 0.05%

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

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


Advanced Ingredient Data


Raw Label Data

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