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 Rockland Cosmetics, 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 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
adults and children under 12 years if 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 propeties 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, yellow 10, green 3
Questions Or Comments?
Call 877-757-5005
Adverse Reaction
Distributed By: Rockland Cosmetics, Inc.
Hillburn, NY
www.RocklandCosmetics.com
Made in the U.S.A. with U.S. and foreign components.
NSK
New Square Kashrus
DSP-TN-21091
DSP-MO-20087
Principal Display Panel
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
mint'evo
REVOLUTIONIZINGG ORAL FRESSNESS
ANTISEPTIC MOUTHWASH
ANTIGINGIVITIS/ANTIPLAQUE
KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND GINGIVITIS THE GUM DISEASE
SPRING MINT
500 Ml (1.05 pt) 16.9 FL OZ
* Please review the disclaimer below.