Equaline 163.005/163ag

Equaline 163.005/163ag
SPL v16
SPL
SPL Set ID 3602c528-5f53-4d41-bf67-163149f52b35
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-09-13

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.02% (0.01% 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 daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 ® Total Care Anticavity Mouthwash.

Adverse Reaction

Like it or let us make it right.

That's our quality promise.

855-423-2360

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Active Ingredient

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

Other Information
  • store at controlled room temperature 20°-25° C to (68°-77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

compare to Listerine ® Total Care Anticavity Mouthwash active ingredient*

EQUALINE ®

multiple benefit

anticavity mouthwash

sodium fluoride and acidulated phosphate topical solution

  • helps strengthen teeth to help prevent cavities
  • helps restore enamel
  • kills germs that cause bad breath

IMPORTANT: read directions for proper use.

mint eucalyptus

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Do Not Use If Band Around Cap Is Broken Or Missing.

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 daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 ® Total Care Anticavity Mouthwash.

Adverse Reaction

Like it or let us make it right.

That's our quality promise.

855-423-2360

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • store at controlled room temperature 20°-25° C to (68°-77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (Principal display panel)

compare to Listerine ® Total Care Anticavity Mouthwash active ingredient*

EQUALINE ®

multiple benefit

anticavity mouthwash

sodium fluoride and acidulated phosphate topical solution

  • helps strengthen teeth to help prevent cavities
  • helps restore enamel
  • kills germs that cause bad breath

IMPORTANT: read directions for proper use.

mint eucalyptus

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Do Not Use If Band Around Cap Is Broken Or Missing.

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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