Therabreath For Kids Anti Cavity Oral Rinse
FDA Label NDC 72551-254

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Harold Katz, Llc for the product Therabreath For Kids Anti Cavity Oral Rinse (NDC 72551-254). 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 active ingredient, purpose, use, warnings, directions, other information, inactive ingredients, therabreath kids anti cavity oral rinse, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Use

Aids in the prevention of dental cavities

Warnings

Keep Out Of Reach of Children.

If more than used for rinsing is accidentally swallowed, get help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a
toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not

swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Consult a dentist or doctor.

Inactive Ingredients

Water, Glycerin, Sodium Benzoate, Xylitol, Sodium Citrate, Citric Acid, Flavor (Organic)

* Please review the disclaimer below.