Equaline 971.001/971ab

Equaline 971.001/971ab
SPL v5
SPL
SPL Set ID 9d055fed-26d8-4827-a4cc-8c314514a6c3
Route
ORAL
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol, Unspecified Form Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01

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

Section 42229-5

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

Warning

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 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 Johnson & Johnson Corporation, distributer or Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Active Ingredient

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

Other Information
  • store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display

NDC 41163-971-86

compare to Listerine ®Total Care Zero Alcohol Mouthwash active ingredient*

EQUALINE ®

burn-free fluoride

anti-cavity

mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • does not contain ethyl alcohol
  • helps strengthen teeth to fight cavities
  • helps restore enamel
  • kills germs that couse bad breath

IMPORTANT: read directions for proper use.

FRESH MINT

1 L (33.8 FL OZ)

Tamper Evident Statement

Sealed With Printed Neckband For Your Portection

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

Section 42229-5 (42229-5)

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

Purpose

Anticavity

Warning

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 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 Johnson & Johnson Corporation, distributer or Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Active Ingredient

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

Other Information (Other information)
  • store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display (Principal panel display)

NDC 41163-971-86

compare to Listerine ®Total Care Zero Alcohol Mouthwash active ingredient*

EQUALINE ®

burn-free fluoride

anti-cavity

mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

  • does not contain ethyl alcohol
  • helps strengthen teeth to fight cavities
  • helps restore enamel
  • kills germs that couse bad breath

IMPORTANT: read directions for proper use.

FRESH MINT

1 L (33.8 FL OZ)

Tamper Evident Statement

Sealed With Printed Neckband For Your Portection

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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