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 Publix Super Markets, Inc. 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
Warnings
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 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 Publix Cool Fresh 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.
Other Safety Information
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine
Adverse Reactions
Distributed by:
Publix Super Markets, Inc.,
3300 Publix Corporate Parkway
Lakeland, FL 33811
publix.com
PUBLIX GUARANTEE:
COMPLETE SATISFACTION OR YOUR MONEY BACK
664.001/664AS
Principal Display Panel
Publix
coolfresh
ANTISEPTIC MOUTH RINSE
kills germs that cause:
- bad breath
- plaque
- the gum disease gingivitis
ADA
Accepted
American
Dental
Association
COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE
1L (33.8 FL OZ)
* Please review the disclaimer below.