Brush Buddies Oral Rinse Clean Mint Mouthwash
FDA Label NDC 70108-164

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc for the product Brush Buddies Oral Rinse Clean Mint (NDC 70108-164). 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, warnings, stop use and ask dentist if, keep out of reach of children under 6 years of age., directions, 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

Warnings

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.

If more than the rinsing amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

  • A dults and children 12 years and older:Measure 20mL (4 teaspoonfuls) and vigorously swish around the mouth and between teeth for 1 minute and then spit out. Use undiluted twice daily, in the morning and before bedtime.
  • Children 6 years to under 12 years:Should be supervised when using this product.
  • Children under 6 years of age:Not recommended for use.
  • Do not swallow.

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, Glycerine, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose, Sodium Chlorite

Questions Or Comments?

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