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  5. Label Information: Anticavity Fluoride Rinse

FDA Label for Anticavity Fluoride Rinse

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNING
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. DISCLAIMER
    10. ADVERSE REACTIONS
    11. PRINCIPAL DISPLAY PANEL

Anticavity Fluoride Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.