Equaline 581.000/581ac

Equaline 581.000/581ac
SPL v10
SPL
SPL Set ID 8283cea0-7b62-4796-8763-6654039664cd
Route
ORAL
Published
Effective Date 2025-02-28
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 2020-10-26

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

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 Mouthwash Cool Mint

Adverse Reaction

Like it or let us make it right.

That is our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

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 Panel Display

compare to Act ®Restoring Anticavity Fluoride Mouthwash*

EQUALINE ®

restoring

anticavity

fluoride

mouthwash

  • restores enamel
  • helps avoid tooth decay

refreshing mint

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

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 Mouthwash Cool Mint

Adverse Reaction (Adverse reaction)

Like it or let us make it right.

That is our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

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 Panel Display (Principal panel display)

compare to Act ®Restoring Anticavity Fluoride Mouthwash*

EQUALINE ®

restoring

anticavity

fluoride

mouthwash

  • restores enamel
  • helps avoid tooth decay

refreshing mint

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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