Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antiseptic Mouthwash
FDA Label NDC 0869-0072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vi Jon, Llc for the product Antiseptic (NDC 0869-0072). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis, Antiplaque
Use
helps control plaque that leads to gingivitis
Warnings
for this product
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.
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.
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
Other Information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).
Inactive Ingredents
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3
Ada Council Statement
“The ADA Council on Scientific Affairs’ Acceptance of Swan Spring Mint® Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.”
Safety Information
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Freshburst Listerine Antiseptic Mouthwash.
DSP-TN-1500 DSP-MO-34 SDS-TN-15012
Adverse Reactions
Distributed By: Vi-Jon, LLC
8515 Page Ave., St. Louis, MO 63114
Questions or Comments? 1-888-593-0593
Principal Display Panel
NDC 0869-0072-69
Sealed With Printed Neckband For Your Protection
SWAN
ANTISEPTIC
MOUTH RINSE
spring mint
Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis
Compare to FreshBurst Listerin
ADA
Accepted
American
Dental
Association
250 mL (8.5 FL OZ)
Image Description (Mm3)
Mountain
Falls
Compare to Listerine
improves oral hygiene
for daily mouth care
kills germs that cause bad breath, plaque and gingivitis gum disease
freshens breath
antiseptic
mouth rinse
antigingivitis/antiplaque
spring mint
500 mL (16.9 FL OZ)
Image Description (Mm4)
* Please review the disclaimer below.
