Brush Buddies Oral Rinse Sparkle Mint Mouthwash
FDA Label NDC 70108-206

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 Sparkle Mint (NDC 70108-206). 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

Sodium Fluoride 0.05% (0.02%w/v fluoride ion)

Purpose

Anti-cavity

Uses:

Helps prevent dental cavities

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

  • Adults and children 18 years and older:Measure 10ml (2 teaspoonful) and vigorously swish around the mouth and between teeth for about 1 minute and expel. Use undiluted, once daily, in morning, after brushing with a toothpaste. Do not eat or drink for atleast 30min. after rinsing.
  • 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, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Thymol, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate, Citric acid, Sodium Chlorite, Flavour

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