Marc's 664.003/664at Rev 2/664au

Marc's 664.003/664at Rev 2/664au
SPL v10
SPL
SPL Set ID f0ac9715-7d9f-48e9-9371-bb7d8be29c66
Route
ORAL
Published
Effective Date 2025-03-07
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 Saccharin Sodium Sodium Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-22

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing
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

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

Distributed by:

Marc Glassman, Inc

West 130th Street

Cleveland, OH 44130

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°-77°F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

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

Principal Display Panel

Marc's®

*Compare to Cool Mint® Listerine® Mouthwash

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

Kills Germs that Cause

  • Bad Breath
  • Plaque
  • Gingivitis Gum Disease

Blue Mint Flavor

1.5 L (1.58 QT) 50.7 FL OZ

Other Safety Information

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 under 12 years of age - consult a dentist or doctor

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

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

Distributed by:

Marc Glassman, Inc

West 130th Street

Cleveland, OH 44130

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°-77°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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Principal Display Panel (Principal display panel)

Marc's®

*Compare to Cool Mint® Listerine® Mouthwash

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

Kills Germs that Cause

  • Bad Breath
  • Plaque
  • Gingivitis Gum Disease

Blue Mint Flavor

1.5 L (1.58 QT) 50.7 FL OZ

Other Safety Information

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 If (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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