Equate Healthy Gums Clean Mint Breath Oral Rinse Liquid
FDA Label NDC 84239-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vasu Healthcare Pvt. Ltd. for the product Equate Healthy Gums Clean Mint Breath Oral Rinse (NDC 84239-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, stop use and ask dentist if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Anti-Gingivitis/Anti-Plaque

Uses

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

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.

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

Package Labelling:

Label.jpg (Label)

Label.jpg (Label)

* Please review the disclaimer below.