Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 36800-213

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 36800-213). 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 Rinse

Use

aids in the prevention of dental cavities

Warning

for this product only

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 now 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 necessay 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, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

Adverse Reactions

DISTRIBUTED BY:TOCO ASSOCIATES LLC

7711 GROSS POINT ROAD, SKOKIE, IL 60077

TOCO VIJ310

QUESTIONS? 1-888-423-0139 [email protected]

213.002/213AE rev 2

Principal Display Panel

TopCare

MINT

Antuicavity

Fluoride

Rinse

  • Strong cavity protection
  • Helps strengthen teeth
  • Helps prevent cavities
  • Freshens breath

    • COMPARE TO ACT

    active ingredient

    IMPORTANT: READ

    DIRECTIONS FOR PROPER USE

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    18 FL OZ (532 mL)

* Please review the disclaimer below.