Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 41250-213

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 Fluoride Rinse (NDC 41250-213). 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, warning, 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.

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

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 childre 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 10 ML mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Other Information

• store at room temperature

Questions

Call 1-888-593-0593

Disclaimer

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

Safety Seal

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Ada Council

"The ADA Council on Scientific Affairs Acceptance of Meijer 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."

Adverse Reactions

DISTRIBUTED BY

MEIJER DISGRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

213.002/213AE rev 2

Principal Display Panel

NDC 41250-213-44

Compare to

Act

active ingredient

meijer

Fresh Mint

Anticavity

Fluoride Rinse

Alcohol Free

Helps prevent cavities

Helps strengthen teeth

Freshens breath

ADA

Accepted

American

Dental

Association

IMPORTANT:

read directions

for proper use

18 FL OZ (532 mL)

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