equate 581.000/581aa-ac

equate 581.000/581aa-ac
SPL v16
SPL
SPL Set ID af5b93e7-5cce-4e01-8df2-54494d8b2910
Route
oral
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.2 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 propylene glycol sodium benzoate sodium phosphate polysorbate 20 saccharin sodium cetylpyridinium chloride sodium phosphate, dibasic, anhydrous edetate calcium disodium anhydrous fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-09-25

Purpose

Anticavity

Description

Sealed with printed neckband for your protection


Medication Information

Purpose

Anticavity

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

Description

Sealed with printed neckband for your protection

Questions?

Call 1-888-287-1915

Use

aids in the prevention of dental cavities

Warning

For this product

Disclaimer

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

Adverse Reaction

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart, Inc., Bentonville, AR 72716

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Made in the USA

with domestic and imported ingredients

Factory Certified

DSP-TN-21091

DSP-MO-20087

Active Ingredient

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

Principal Panel Display

equate ™

NDC 49035-581-86

Compare to Act Restoring ®Anticavity Fluoride Mouthwash Coll Mint active ingredient*

Restoring Anticavity Fluoride Mouthwash

Refreshing Mint

Restores enamel

Helps remineralize soft spots

IMPORTANT: read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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

Purpose

Anticavity

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 (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 1-888-287-1915

Use

aids in the prevention of dental cavities

Warning

For this product

Disclaimer

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

Adverse Reaction (Adverse reaction)

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart, Inc., Bentonville, AR 72716

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Made in the USA

with domestic and imported ingredients

Factory Certified

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

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

Principal Panel Display (Principal panel display)

equate ™

NDC 49035-581-86

Compare to Act Restoring ®Anticavity Fluoride Mouthwash Coll Mint active ingredient*

Restoring Anticavity Fluoride Mouthwash

Refreshing Mint

Restores enamel

Helps remineralize soft spots

IMPORTANT: read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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

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