Equaline 435.000/435aa

Equaline 435.000/435aa
SPL v17
SPL
SPL Set ID dd6bf8df-1e28-4f61-b876-b9f1f8d5993a
Route
ORAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Alcohol Hydrogen Peroxide Poloxamer 407 Saccharin Sodium Water Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-18

Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Adverse Reactions

Like it or let us make it right. That's out quality promise. 855-423-2630 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA DSP-TN-210091 DSP-MO-20087


Medication Information

Purpose

Anticavity

Adverse Reactions

Like it or let us make it right. That's out quality promise. 855-423-2630 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA DSP-TN-210091 DSP-MO-20087

Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Tep

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 Kenvue, Inc., distributor of Listerine ® HealthyWhite ® Vibrant Anticavity Fluoride Mouthrinse.

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

Store at room temperature (59º-77ºF)

Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

compare to Listerine ® HealthyWhite ® Vibrant Anticavity Fluoride Mouthrinse active ingredient*

EQUALINE ®

glowing white

anticavity

mouthrinse

  • begins working on contact
  • 5 days to whiter teeth
  • helps strengthen teeth
  • kills germs that cause bad breath

IMPORTANT: read directions for proper use.

fresh mint

32 FL OZ (1 QT) 946 mL

Adverse Reactions Section

Like it or let us make it right.

That's out quality promise.

855-423-2630

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

DSP-TN-210091

DSP-MO-20087

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

Tep (TEP)

Sealed With Printed Neckband For Your Protection

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 Kenvue, Inc., distributor of Listerine ® HealthyWhite ® Vibrant Anticavity Fluoride Mouthrinse.

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)

Store at room temperature (59º-77ºF)

Inactive Ingredients (Inactive ingredients)

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel (Principal display panel)

compare to Listerine ® HealthyWhite ® Vibrant Anticavity Fluoride Mouthrinse active ingredient*

EQUALINE ®

glowing white

anticavity

mouthrinse

  • begins working on contact
  • 5 days to whiter teeth
  • helps strengthen teeth
  • kills germs that cause bad breath

IMPORTANT: read directions for proper use.

fresh mint

32 FL OZ (1 QT) 946 mL

Adverse Reactions Section (Adverse reactions section)

Like it or let us make it right.

That's out quality promise.

855-423-2630

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

DSP-TN-210091

DSP-MO-20087

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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