Anticavity Mouthwash
FDA Label NDC 41250-581

12 label sections · Submitted to the FDA by Meijer, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Anticavity (NDC 41250-581). 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 tamper evident statement, 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

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active Ingredient

Sodium fluoride 0.02% (0.009% 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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a 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
  • 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 (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Questions?

Call 1-888-593-0593

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Restoring Anticavity Fluoride Mouthwash Cool Mint.

Adverse Reaction

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

The Meijer Family

WWW.MEIJER.COM/sATISFACTION

DSP-TN-21091

DSP-MO-20087

Principal Display Panel

NDC 41250-581-86

meijer ®

Compare to Act ® Restoring Anticavity Fluoride Mouthwash Active Ingredient*

RESTORING ANTICAVITY

Fluoride Rinse

Sodium Fluoride And Acidulated Phosphate Topical Solution

RESTORES ENAMEL

Refreshing Mint

Helps strengthen teeth

Helps remineralize soft spots

Freshens breath

IMPORTANT: Read directions for proper use

33.8 FL OZ (1 L) 1.05 QT

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* Please review the disclaimer below.