Meijer 581.000/581aa-ac

Meijer 581.000/581aa-ac
SPL v12
SPL
SPL Set ID acff939e-e98c-4d89-a0c4-0254dc74e672
Route
ORAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Anhydrous Fd&c Blue No. 1 Water Alcohol Sorbitol Poloxamer 407 Propylene Glycol Sodium Benzoate Sodium Phosphate Polysorbate 20 Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-18

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warnings

For this product

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
Disclaimer

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

Questions?

Call 1-888-593-0593

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

Active Ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

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

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

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, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

For this product

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
Disclaimer

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

Questions?

Call 1-888-593-0593

Adverse Reaction (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

Active Ingredient (Active ingredient)

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Inactive Ingredients (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

Principal Display Panel (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

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, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)