Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 56062-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc. for the product Anticavity Fluoride Rinse (NDC 56062-163). 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 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Warnings

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other Information

  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Other

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811 publix.com

Principal Display Panel

Publix

EUCALYPTUS MINT

anticavity

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • Helps prevent cavities
  • Restores enamel
  • Helps strengthen teeth
  • Helps kill germs that cause bad breath

    • Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash*

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    IMPORTANT: READ DIRECTIONS FOR PROPER USE.

    1 L (33.8 FL OZ)

    163.004/163AE

    Image Description (Mm1)

    Image Description (Mm1)

* Please review the disclaimer below.