Active Ingredients
Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 0.060%, Thymol 0.064%
Antiseptic Mouthrinse Mouthwash
FDA Label NDC 67860-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cariba International for the product Antiseptic Mouthrinse (NDC 67860-072). 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 if, 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 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)
Image Description (Mm3)
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