Publix 072.003/072al Rev 2 - 072an

Publix 072.003/072al Rev 2 - 072an
SPL v13
SPL
SPL Set ID 04eb6dfd-bdb7-46f3-930e-9c900fdd0b5b
Route
ORAL
Published
Effective Date 2025-03-11
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 Solution Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1998-01-06

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 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine.

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

Distributed by: Publix Super Markets, Inc.,

3300 Publix Corporate Parkway

Lakeland, FL 33811 publix.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Publix

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature.

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C  yellow no.10, FD&C green no. 3

Principal Display Panel

P

fresh spearmint

ANTIGINIVITIS/ANTIPLAQUE

MOUTHRINSE

kills germs that cause:

  • bad breath
  • plaque
  • the gum disease gingivitis

ADA Accepted 

American Dental Association

  • Help reduce plaque
  • Helps reduce gingivitis

*COMPARE TO THE ACTIVE INGREDIENTS OF FreshBurst LISTERINE ®

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

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 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
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine.

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)

Distributed by: Publix Super Markets, Inc.,

3300 Publix Corporate Parkway

Lakeland, FL 33811 publix.com

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

Publix

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information (other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature.

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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C  yellow no.10, FD&C green no. 3

Principal Display Panel (principal display panel)

P

fresh spearmint

ANTIGINIVITIS/ANTIPLAQUE

MOUTHRINSE

kills germs that cause:

  • bad breath
  • plaque
  • the gum disease gingivitis

ADA Accepted 

American Dental Association

  • Help reduce plaque
  • Helps reduce gingivitis

*COMPARE TO THE ACTIVE INGREDIENTS OF FreshBurst LISTERINE ®

33.8 FL OZ (1.05 QT) 1 L

Tamper Evident Statement

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. (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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