SPL v5
SPL
SPL Set ID 411be334-364c-4074-8d0b-8dda332f87de
Route
ORAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (2.3 g)
Inactive Ingredients
Propolis Wax Turmeric Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-02

Description

Cetylpyridinium Chloride 2.30%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium Chloride 2.30%

Uses

■ Helps prevent and reduce plaque and gingivitis

■ Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Section 51945-4

Warnings

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

■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

■ gingivitis, bleeding or redness persists for more than 2 weeks

■ you have painful or swollen gum, pus from the gumline, loose teeth, or increasing spacing between the teeth. Theses may be signs or symptoms of periodontitis, a serious form of gum disease.

Questions

■ https://docsmedi.kr

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

Directions

■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).

■ Adults and children 12 years of age and older: vigorously 1/2 oz. (20ml) of rinse, twice a day, for 30seconds and then spit out.

■ Children 6 years to under 12 years: supervise use.

■ Children under 6 years of age: do not use

Active Ingredient

Cetylpyridinium Chloride 2.30%

Other Information

■ Airtight container, Store in normal temperature 1~30°C (34~86°F)

Inactive Ingredients

Chitosan, Propolis extract, Turmeric root extract, D-sorbitol solution, Grapefruit seed extract, Peppermint flavor Xylitol, Enzymatically modified stevia, Taraxacum platycarpum extract, Green tea extract, Gardenia Blue, Purified water

Keep Out of Reach of Children

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

■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

■ Helps prevent and reduce plaque and gingivitis

■ Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antigingivitis, Antiplaque

Warnings (WARNINGS)

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

■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

■ gingivitis, bleeding or redness persists for more than 2 weeks

■ you have painful or swollen gum, pus from the gumline, loose teeth, or increasing spacing between the teeth. Theses may be signs or symptoms of periodontitis, a serious form of gum disease.

Questions

■ https://docsmedi.kr

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

Directions

■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).

■ Adults and children 12 years of age and older: vigorously 1/2 oz. (20ml) of rinse, twice a day, for 30seconds and then spit out.

■ Children 6 years to under 12 years: supervise use.

■ Children under 6 years of age: do not use

Active Ingredient (ACTIVE INGREDIENT)

Cetylpyridinium Chloride 2.30%

Other Information

■ Airtight container, Store in normal temperature 1~30°C (34~86°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Chitosan, Propolis extract, Turmeric root extract, D-sorbitol solution, Grapefruit seed extract, Peppermint flavor Xylitol, Enzymatically modified stevia, Taraxacum platycarpum extract, Green tea extract, Gardenia Blue, Purified water

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

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

■ if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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