411be334-364c-4074-8d0b-8dda332f87de

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

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium Chloride 2.30%


Medication Information

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.

Uses

■ Helps prevent and reduce plaque and gingivitis

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

Purpose

Antigingivitis, Antiplaque

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

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

Description

Cetylpyridinium Chloride 2.30%

Section 51945-4

Questions

■ https://docsmedi.kr

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

Active Ingredient

Cetylpyridinium Chloride 2.30%

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

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.

Uses

■ Helps prevent and reduce plaque and gingivitis

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

Purpose (PURPOSE)

Antigingivitis, Antiplaque

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

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

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 2.30%

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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