Tep
Sealed With Printed Neckband For Your Protection
Antispetic Mouthwash
FDA Label NDC 67860-664
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 Antispetic (NDC 67860-664). 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 tep, active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 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 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 atiseptic 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
Adverse Reactions
Distributed by:
Cariba International
P.O. Box 1208
Safety Harbor, Florida 34695
MADE IN USA WITH US AND
FOREIGN COMPONENTS
664.002/664AS
Principal Display Panel
CARIBA
ANTISEPTIC
MOUTHWASH
ANTIGINGIVITIS/ANTIPLAQUE
BLUE MINT
Kills germs that cause
Bad Breath, Plaque
& the gum disease
Gingivitis
1 L (33.8 FL OZ)
Image Description (Mm3)
Image Description (Mm3)
* Please review the disclaimer below.
