Cvs 318.003/318ai

SPL v26

SPL

SPL Set ID 204025ac-af00-48a0-be8e-7ccc7a36ad45

Route

ORAL

Published

Effective Date 2026-01-09

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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-05-12

Description

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

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

Made in the U.S.A. of U.S. and foreign components

DSP-TN-21091

DSP-MO-20087

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

do not swallow
not intended to replace brushing or flossing

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

children under 12 years of age - consult a dentist or doctor

Disclaimer

*This product is manufactued or distributed by Kenvue, Inc., distributor of Listerine ^®Original 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.

Other Information

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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel

Sealed with printed neckband for your protection.

CVS™

Antiseptic Mouthwash

Antigingivitis & Antiplaque

Original Flavor

Compare to Listerine ^®Original Antiseptic Mouthwash*

Kills germs that cause plaque, gingivitis & bad breath

ADA Accepted

American Dental Association

Helps prevent and reduce plaque
Helps prevent and reduce gingivitis

8.5 FL OZ (250 mL)

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

do not swallow
not intended to replace brushing or flossing

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

children under 12 years of age - consult a dentist or doctor

Disclaimer

*This product is manufactued or distributed by Kenvue, Inc., distributor of Listerine ^®Original Antiseptic Mouthwash.

Do Not Use (Do not use)

Adverse Reactions (Adverse reactions)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

Made in the U.S.A. of U.S. and foreign components

DSP-TN-21091

DSP-MO-20087

Other Information (Other information)

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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection.

CVS™

Antiseptic Mouthwash

Antigingivitis & Antiplaque

Original Flavor

Compare to Listerine ^®Original Antiseptic Mouthwash*

Kills germs that cause plaque, gingivitis & bad breath

ADA Accepted

American Dental Association

Helps prevent and reduce plaque
Helps prevent and reduce gingivitis

8.5 FL OZ (250 mL)

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "ACTIB", "strengthNumerator": "0.92", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.42", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "ACTIB", "strengthNumerator": "0.64", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "helps control plaque that leads to gingivitis", "Purpose": "Antigingivitis, Antiplaque", "Warnings": "For this product", "Directions": "do not swallow not intended to replace brushing or flossing 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 children under 12 years of age - consult a dentist or doctor", "Disclaimer": "*This product is manufactued or distributed by Kenvue, Inc., distributor of Listerine ® Original 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 reactions": "Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2025 CVS/pharmacy CVS.com 1-800-SHOP CVS Made in the U.S.A. of U.S. and foreign components DSP-TN-21091 DSP-MO-20087", "Other information": "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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel", "principal display panel": "Sealed with printed neckband for your protection. CVS™ Antiseptic Mouthwash Antigingivitis & Antiplaque Original Flavor Compare to Listerine ® Original Antiseptic Mouthwash* Kills germs that cause plaque, gingivitis & bad breath ADA Accepted American Dental Association Helps prevent and reduce plaque Helps prevent and reduce gingivitis 8.5 FL OZ (250 mL)", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.892179 · Updated: 2026-03-14T23:12:45.219834