Swan 072.003/072al Rev 2 - An

Swan 072.003/072al Rev 2 - An
SPL v4
SPL
SPL Set ID b60be9d4-cf1c-4d4d-b15b-20630b0a4be4
Route
ORAL
Published
Effective Date 2025-03-20
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 Citrate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-08-15

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 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 Kenvue, Inc., distributor of FreshBurst ®Listerine ®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.

Questions?

Call 1-888-593-0593

Adverse Reaction

DISTRIBUTED BY:

Consumer Product Partners, LLC,

St. Louis, MO 63114

DSP-TN-21091

DSP-MO-20087

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, flavor, sodium citrate, yellow 10, green 3

Principal Panel Display

Sealed With Printed Neckband For Your Protection

swan ®

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

spring mint ®

Kills Germs that Cause Bad Breath, Plaque & the Gum Disease Gingivitis.

Compare to Listerine ® Antiseptic Mouthwash*

ADA ACCEPTED

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

500 mL (1.05 PT) 16.9 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 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 Kenvue, Inc., distributor of FreshBurst ®Listerine ®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.

Questions?

Call 1-888-593-0593

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY:

Consumer Product Partners, LLC,

St. Louis, MO 63114

DSP-TN-21091

DSP-MO-20087

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, flavor, sodium citrate, yellow 10, green 3

Principal Panel Display (Principal panel display)

Sealed With Printed Neckband For Your Protection

swan ®

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

spring mint ®

Kills Germs that Cause Bad Breath, Plaque & the Gum Disease Gingivitis.

Compare to Listerine ® Antiseptic Mouthwash*

ADA ACCEPTED

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

500 mL (1.05 PT) 16.9 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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