Anticavity Rinse Mouthwash
FDA Label NDC 41250-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Anticavity Rinse (NDC 41250-004). 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, 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 0.05% (0.02%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, seep 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
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above the 10mL 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 years of age: consult a dentist or doctor

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

Other Information

  • store at room temperature  

Claims

Sealed with printed neckband for your protection

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

"The ADA council on Scientific Affairs Acceptance of Meijer Kids Anticavity Fluoride Rinse is based on the finding that the product is effective in

helping to prevent and reduce tooth decay, when used as directed."

Adverse Reactions

Distributed by Meijer Distribution, Inc.

Grand Rapids, MI 49544

www.meijer.com

004.002/004AE

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Compare to Act active ingredient

NDC 41250-004-44

meijer

kids!

anticavity fluoride rinse

alcohol free

Bubble Gum

ADA

Accepted

American

Dental

Association

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

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