Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 59779-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Anticavity Fluoride Rinse (NDC 59779-163). 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, inactive ingredients, other information, 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% fluoride ion)

Purpose

Antcavity

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 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit it 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

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 Information

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

Other

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2017 CVS/pharmacy
www.cvs.com 1-800-shop-CVS

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Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash

Anticavity Fluoride Mouthwash

SODIUM FLUORIDE

6 Benefits:

  • Restores enamel
  • Helps prevent cavities
  • Cleans entire mouth
  • Kills bad breath germs
  • Strengthens teeth
  • Freshens breath

    • Eucalyptus Mint

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    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.