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


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