FDA Label for Antispetic
View Indications, Usage & Precautions
Antispetic Product Label
The following document was submitted to the FDA by the labeler of this product Liberty Chemical Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Purpose
Antigingivitis, antiplaque
Use
help 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
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° and 77° F)
Inactive Ingredients
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 Statement
The ADA Council on Scientific Affairs Acceptance of Core Values Fresh 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.
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.
Adverse Reactions
Distributed by
Liberty Procurement, Inc.
650 Liberty Ave.
Union, NJ 07083 USA
Visit us at: www.facevalues.com
072.001/072AL
Principal Display Panel
CORE VLAUES
Compare to Listerine FreshBurst
Fresh Mint
MOUTHWASH
ANTISEPTIC
Antigingvitis/Antiplaque
Mouth Rinse
Kills Germs that Cause
Bad Breath. Plaque &
the Gum Disease Gingivitis
ADA
Accepted
American
Dental
Association
1 LITER (1 QT 1.8 FL OZ)
Sealed With Printed Neckband For Your Protection
* Please review the disclaimer below.
