FDA Label for Antiseptic Mouthrinse
View Indications, Usage & Precautions
Antiseptic Mouthrinse Product Label
The following document was submitted to the FDA by the labeler of this product Cariba International. 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 sailcylate 0.060%, Thymol 0.064%
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 incresed 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 rednss 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
do not swallow - not intended to replace brushing or flossing
adults and and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonful) between teeth twice a day for 30 seconds then spit out
children under 12 years of age consult a dentist or doctor
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 citrate, D&C yellow no. 10, FD&C green no.3
Adverse Reactions Section
Distributed by:
Cariba International
P.O. Box 1208
Safety Harbor, Florida 34695
MADE IN USA WITH
US AND FOREIGN
COMPONENTS
072.002/072AL
Principal Display Panel
Sealed with Printed Neckband for your Protection
CARIBA
ANTISEPTIC
Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
FRESH MINT
Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis
250 mL (8.5 FL OZ)
* Please review the disclaimer below.