Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 11344-004

12 label sections · Submitted to the FDA by Nice-pak Products, Llc · 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, other information, 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 

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 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.
  • 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

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

Disclaimer

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

Adverse Reaction

Distributed by: Consumer Product Partners, LLC, 

St. Louis, MO 63114, 1-888-593-0593

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 Kids Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

ADA Accepted

American Dental Association

Helps prevent cavities

18 FL OZ (1.12 PT) 532 mL 

Image Description (Mm01)

Image Description (Mm01)

Image Description (Mm02)

Image Description (Mm02)

* Please review the disclaimer below.