Swan 664.003/664at Rev2-au

Swan 664.003/664at Rev2-au
SPL v16
SPL
SPL Set ID 8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1
Route
ORAL
Published
Effective Date 2025-05-12
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 Completed Since 1992-07-15 Until 2019-12-01

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

Section 34084-4

Distributed by: Vi-Jon 

One Swan Drive

Smyrna, TN 37167

DSP-TN-15000

DSP-MO-34 SDS-TN-15012

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 Cool Mint 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.

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Other Information 

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59º-77ºF).

Inactive Ingredients

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

Ada Council Statement

The ADA Council on scientific affairs Acceptance of Swan Blue Mint Antiseptic mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

Principal Display Panel

Sealed With Printed Neckband For Your Protection

NDC 0869-0664-77

Swan ®

ANTISEPTIC

MOUTH RINSE

ice mint ®

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

Compare to active ingredients of Listerine ®*

ADA Accepted

American Dental Association

500 mL (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

Section 34084-4 (34084-4)

Distributed by: Vi-Jon 

One Swan Drive

Smyrna, TN 37167

DSP-TN-15000

DSP-MO-34 SDS-TN-15012

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 Cool Mint 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.

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Other Information  (Other information )

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59º-77ºF).

Inactive Ingredients (Inactive ingredients)

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

Ada Council Statement (ADA Council Statement)

The ADA Council on scientific affairs Acceptance of Swan Blue Mint Antiseptic mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

Principal Display Panel (principal display panel)

Sealed With Printed Neckband For Your Protection

NDC 0869-0664-77

Swan ®

ANTISEPTIC

MOUTH RINSE

ice mint ®

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

Compare to active ingredients of Listerine ®*

ADA Accepted

American Dental Association

500 mL (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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