Swan 163.005/163af-ag

SPL v3

SPL

SPL Set ID 2a4c9882-59e0-49cc-a4a3-f2bb4a7f9504

Route

ORAL

Published

Effective Date 2025-07-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Thymol Sodium Phosphate, Dibasic Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-05-13

Description

Sodium fluoride 0.02% (0.01% Fluoride ion)

Purpose

Anticavity

Adverse Reactions

Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 DSP-TN-21091 DSP-MO-20087

Medication Information

Purpose

Anticavity

Adverse Reactions

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

DSP-TN-21091

DSP-MO-20087

Description

Sodium fluoride 0.02% (0.01% Fluoride ion)

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ^®Total Care Fresh Mint Anticavity Mouthwash.

Active Ingredient

Sodium fluoride 0.02% (0.01% Fluoride ion)

Other Information

store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

Sealed With Printed Neckband For Your Protection

Swan _®

ANTICAVITY

Fluoride Rinse

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

eucalyptus mint

Restores Enamel
Freshens Breath
Helps Prevent Cavities
Helps Strengthen Teeth
Helps Kill Germs That Cause Bad Breath

Compare Listerine ^®Total Care Fresh Mint Anticavity Mouthwash*

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 LITER (1.05 QT) 33.8 FL OZ

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

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ^®Total Care Fresh Mint Anticavity Mouthwash.

Active Ingredient (Active ingredient)

Sodium fluoride 0.02% (0.01% Fluoride ion)

Adverse Reactions (Adverse reactions)

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

DSP-TN-21091

DSP-MO-20087

Other Information (Other information)

store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (Principal display panel)

Sealed With Printed Neckband For Your Protection

Swan _®

ANTICAVITY

Fluoride Rinse

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

eucalyptus mint

Restores Enamel
Freshens Breath
Helps Prevent Cavities
Helps Strengthen Teeth
Helps Kill Germs That Cause Bad Breath

Compare Listerine ^®Total Care Fresh Mint Anticavity Mouthwash*

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 LITER (1.05 QT) 33.8 FL OZ

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

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "for this product", "Directions": "Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor", "Disclaimer": "*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Fresh Mint Anticavity Mouthwash.", "Active ingredient": "Sodium fluoride 0.02% (0.01% Fluoride ion)", "Adverse reactions": "Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 DSP-TN-21091 DSP-MO-20087", "Other information": "store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F) cold weather may temporarily cloud this product", "Inactive ingredients": "water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1", "Principal display panel": "Sealed With Printed Neckband For Your Protection Swan ® ANTICAVITY Fluoride Rinse SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION eucalyptus mint Restores Enamel Freshens Breath Helps Prevent Cavities Helps Strengthen Teeth Helps Kill Germs That Cause Bad Breath Compare Listerine ® Total Care Fresh Mint Anticavity Mouthwash* IMPORTANT: READ DIRECTIONS FOR PROPER USE 1 LITER (1.05 QT) 33.8 FL OZ", "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: 2026-02-15T12:06:32.490586 · Updated: 2026-03-14T23:09:21.323328