equate healthy gums clean mint breath oral rinse

equate healthy gums clean mint breath oral rinse
SPL v3
SPL
SPL Set ID 05fc922a-73fc-4826-be77-538da08282b9
Route
topical
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.5 mg)
Inactive Ingredients
water glycerin polyoxyl 40 hydrogenated castor oil sodium benzoate citric acid monohydrate sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-25

Purpose

Anti-Gingivitis/Anti-Plaque

Description

Cetylpyridinium Chloride 0.05%


Medication Information

Uses
  • Helps reduce Plaque-associated Gingivitis
  • Helps control gum infections
Purpose

Anti-Gingivitis/Anti-Plaque

Directions

Adults and children 12 years and older : Measure 20ml (4 teaspoonful) and vigorously swish around the mouth and between teeth for 1 minute then spit out. Use undiluted, twice daily, in morning & before bedtime.

Children 6 years to under 12 years : Under Adult supervision

Children under 6 years : Not recommended for use

  • Do not swallow. In case as excess quantity is swallowed accidently, contact Poison Control Center for immediate care and attention.
Other Information

Do not exceed the recommended dosage. This rinse is not a substitute for brushing or flossing. Do not use if safety seal is broken or missing.

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose

Description

Cetylpyridinium Chloride 0.05%

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.05%

Package Labelling:

Stop Use and Ask 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 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.


Structured Label Content

Uses
  • Helps reduce Plaque-associated Gingivitis
  • Helps control gum infections
Purpose

Anti-Gingivitis/Anti-Plaque

Directions

Adults and children 12 years and older : Measure 20ml (4 teaspoonful) and vigorously swish around the mouth and between teeth for 1 minute then spit out. Use undiluted, twice daily, in morning & before bedtime.

Children 6 years to under 12 years : Under Adult supervision

Children under 6 years : Not recommended for use

  • Do not swallow. In case as excess quantity is swallowed accidently, contact Poison Control Center for immediate care and attention.
Other Information (Other information)

Do not exceed the recommended dosage. This rinse is not a substitute for brushing or flossing. Do not use if safety seal is broken or missing.

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.05%

Package Labelling:

Stop Use and Ask Dentist If (Stop use and ask 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 teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children  (Keep out of reach of children )

under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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