Equaline 855.000/855aa-ac

Equaline 855.000/855aa-ac
SPL v15
SPL
SPL Set ID 263bed7e-b0fa-4a89-a4bd-4e6ae1e10687
Route
ORAL
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Zinc Chloride Sodium Benzoate Sucralose Saccharin Sodium Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-20 Until 2023-01-04

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Listerine ®Ultraclean ®Cool Mint Antiseptic Mouthwash.

Do Not Use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction

Sealed With Printed Neckband For Your Protection

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI Providence, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

 water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

Principal Display Panel

NDC 41163-855-86

compare to Listerine ®Ultraclean ®Cool Mint ®active ingredients*

EQUALINE ®

tartar control plus

antiseptic

mouthrinse

antigingivitis/antiplaque

  • kills germs that cause bad breath, plaque & the gum disease gingivitis

blue mint

1 L (33.8 FL OZ)

Stop Use and Ask A Dentist If

gingivitis, bleeding, or redness persists for more than 2 weeks.

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

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Listerine ®Ultraclean ®Cool Mint Antiseptic Mouthwash.

Do Not Use (Do not use)

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction (ADVERSE REACTION)

Sealed With Printed Neckband For Your Protection

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI Providence, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Other Information (Other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

 water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

Principal Display Panel (Principal display panel)

NDC 41163-855-86

compare to Listerine ®Ultraclean ®Cool Mint ®active ingredients*

EQUALINE ®

tartar control plus

antiseptic

mouthrinse

antigingivitis/antiplaque

  • kills germs that cause bad breath, plaque & the gum disease gingivitis

blue mint

1 L (33.8 FL OZ)

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or redness persists for more than 2 weeks.

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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