Anticavity Rinse Mouthwash
FDA Label NDC 72288-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Anticavity Rinse (NDC 72288-004). 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 active ingredient, purpose, use, warnings, 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% (0.2% 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 accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 year 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 year 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

Adverse Reactions

The ADA Council on Scientific Affairs' Acceptance of Publix Kids Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.

Sealed with printed neckband for your protection

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

Distributed by Publix Super Markets, Inc.

3300 Publix Corporate Parkway

Lakeland, FL 33811

publix.com

004.002/004AE

Principal Display Panel

Solimo

Kids Anticavity Fluoride Rinse

Bubble gum

Alcohol free

IMPORTANT: RAD DIRECTIONS FOR PROPER USE

16.9 FL OZ (500 mL)

Image Description (Mm3)

Image Description (Mm3)

* Please review the disclaimer below.