equate healthy mouth oral rinse -minty bliss

equate healthy mouth oral rinse -minty bliss
SPL v4
SPL
SPL Set ID 1cc1f6fd-67d4-b314-e063-6294a90ab995
Route
oral
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.05 g)
Inactive Ingredients
sucralose sodium phosphate dibasic dihydrate glycerin poloxamer 407 anhydrous citric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-30

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium Chloride 0.05%


Medication Information

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 and older Vigorously swish 20 milliliters (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 Do not use.
Other Information
  • Do not use if the printed safety seal on the bottle's neck is broken or missing.
  • This rinse is not intended to replace brushing or flossing.
Inactive Ingredients

Purified Water, Glycerin, Poloxamer 407, Flavor, Sucralose, Disodium Phosphate, Citric Acid

Description

Cetylpyridinium Chloride 0.05%

Principal Display Panel

Active Ingredients

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 periodontitis, 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.


Structured Label Content

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 and older Vigorously swish 20 milliliters (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 Do not use.
Other Information (Other information)
  • Do not use if the printed safety seal on the bottle's neck is broken or missing.
  • This rinse is not intended to replace brushing or flossing.
Inactive Ingredients (Inactive ingredients)

Purified Water, Glycerin, Poloxamer 407, Flavor, Sucralose, Disodium Phosphate, Citric Acid

Principal Display Panel (Principal display panel)

Active Ingredients (Active ingredients)

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 periodontitis, 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)