Meijer 213.002/213ae Rev 2

Meijer 213.002/213ae Rev 2
SPL v15
SPL
SPL Set ID d85ce60c-ebff-461f-827a-10fddb9c2bf3
Route
ORAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Menthol Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Edetate Disodium Anhydrous Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-07-11

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com OUR QUALITY GUARANTEE WWW.MEIJER.COM/SATISFACTION PID 349230


Medication Information

Purpose

Anticavity rinse

Adverse Reactions

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

WWW.MEIJER.COM/SATISFACTION

PID 349230

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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

Disclaimer

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

Questions?

1-888-593-0593

Active Ingredient

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

Other Information
  • store at room temperature
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

Principal Display Panel

NDC 41250-213-44

meijer ®

Anticavity Fluoride Rinse

COMPARE TO ACT ® ACTIVE INGREDIENT*

Alcohol Free

MINT FLAVOR

Helps prevent cavities

Helps strengthen teeth

Freshens breath

ADA Accepted

American Dental Association

Helps prevent cavities

IMPORTANT: Read directions for proper use.

18 FL OZ (1.12 pt) 532 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • 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

Disclaimer

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

Questions?

1-888-593-0593

Active Ingredient (Active ingredient)

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

Adverse Reactions

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

WWW.MEIJER.COM/SATISFACTION

PID 349230

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (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

Principal Display Panel (Principal display panel)

NDC 41250-213-44

meijer ®

Anticavity Fluoride Rinse

COMPARE TO ACT ® ACTIVE INGREDIENT*

Alcohol Free

MINT FLAVOR

Helps prevent cavities

Helps strengthen teeth

Freshens breath

ADA Accepted

American Dental Association

Helps prevent cavities

IMPORTANT: Read directions for proper use.

18 FL OZ (1.12 pt) 532 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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