Publix 664.003/664at Rev 2-664au

Publix 664.003/664at Rev 2-664au
SPL v14
SPL
SPL Set ID 1046b6b5-b439-4d32-87b3-c118a58bf191
Route
ORAL
Published
Effective Date 2025-05-06
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 1994-03-30

Description

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

Purpose

Antigingivitis, antiplaque

Adverse Reactions

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


Medication Information

Purpose

Antigingivitis, antiplaque

Adverse Reactions

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

Description

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

Use

helps control plaque that leads to gingivitis

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 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.

Warnings 

for this product

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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel

P

cool

fresh

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills germs that cause :

  • Bad breath
  • Plaque
  • The gum disease gingivitis

ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

*Compare to the active ingredients of 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

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 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.

Warnings 

for this product

Adverse Reactions

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 (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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel (principal display panel)

P

cool

fresh

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills germs that cause :

  • Bad breath
  • Plaque
  • The gum disease gingivitis

ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

*Compare to the active ingredients of 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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