Antispetic
Swan 664.003/664AT rev2-AU Blue Mint Antiseptic Mouthrinse
8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1
HUMAN OTC DRUG LABEL
May 12, 2025
Vi-Jon, LLC
DUNS: 088520668
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eucalyptol, menthol, methyl salicylate, thymol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.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)
INDICATIONS & USAGE SECTION
Use
helps control plaque that leads to gingivitis
ADVERSE REACTIONS SECTION
Distributed by: Vi-Jon
One Swan Drive
Smyrna, TN 37167
DSP-TN-15000
DSP-MO-34 SDS-TN-15012
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
OTC - PURPOSE SECTION
Purpose
Antigingivitis, antiplaque
WARNINGS SECTION
Warnings
for this product
OTC - DO NOT USE SECTION
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.
OTC - STOP USE SECTION
Stop use and ask a dentist if
gingivitis, bleeding, or redness persists for more than 2 weeks.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59º-77ºF).
INACTIVE INGREDIENT SECTION
Inactive ingredients
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3
SPL UNCLASSIFIED SECTION
Disclaimer
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.