Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 11344-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Anticavity Fluoride Rinse (NDC 11344-004). 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 claims, active ingredient, purpose, use, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Claims

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

Active Ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

for this product

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentaly 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 the 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

Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other Information

  • store at room temperature

Disclaimer

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

Adverse Reaction

Distributed by: Vi-Jon, LLC, One Swan Drive, Smyrna, TN 37167

Principal Display Panel

Sealed With Printed Neckband For Your Protection

SWAN

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

bubble gum FLAVOR

Strong Cavity Protection

Compare to the active ingredient of Act ®Bubblegum Blowout Anticavity Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.