gn anti-gingivitis oral rinse

gn anti-gingivitis oral rinse
SPL v6
SPL
SPL Set ID 386f8d92-8186-eed7-e063-6394a90a87e1
Route
oral
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.05 g)
Inactive Ingredients
disodium phosphate glycerin stevia leaf citric acid poloxamer 407 water spearmint oil lemon oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-01
Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium Chloride 0.05%

Medication Information

Warnings

Warnings

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Purpose

Antigingivitis/Antiplaque

Directions

Adults and children 12 years of age and older: Vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

Children 6 years to under 12 years: Supervise use.

Children under 6 years of age: Do not use.

Other Information
  • Do not use if printed safety seal on the bottle's neck is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water

Description

Cetylpyridinium Chloride 0.05%

Section 51945-4

Active Ingredient

Cetylpyridinium Chloride 0.05%

Stop Use and Ask A Dentist If
  • Gingivitis, bleeding, or redness persists for more than 2 weeks
  • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontits, a serious form of gum disease
Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Structured Label Content

Warnings

Warnings

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Purpose

Antigingivitis/Antiplaque

Directions

Adults and children 12 years of age and older: Vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

Children 6 years to under 12 years: Supervise use.

Children under 6 years of age: Do not use.

Other Information
  • Do not use if printed safety seal on the bottle's neck is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water

Section 51945-4 (51945-4)

Active Ingredient

Cetylpyridinium Chloride 0.05%

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • Gingivitis, bleeding, or redness persists for more than 2 weeks
  • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontits, a serious form of gum disease
Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.573730 · Updated: 2026-03-14T23:12:30.242816