Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 76162-838

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Anticavity Fluoride Rinse (NDC 76162-838). 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, warning, keep out of reach of children., directions, other information, inactive ingredients, 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)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

For this product

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
  • 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

Other Information

  • store at room temperature

Inactive Ingredients

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Questions Or Comments?

1-888-423-0139

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO VIJA0624

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

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QUALITY GUARANTEED

Disclaimer

*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath® for Kids! Oral Rinse 

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COMPARE TO THERABREATH ® FOR KIDS! ORAL RINSE*

TopCare ®everyday

Kids Anticavity

Fluoride Oral Rinse

Watermelon Flavored

  • Helps prevent cavites & strengthens teeth
  • Dye, Paraben, Alcohol, and Sugar Free

    • IMPORTANT: read directions for proper use.

    10 FL OZ (296 mL)

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