FDA Label for Antiseptic Mouth Rinse

View Indications, Usage & Precautions

Antiseptic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Retail Business Services, Llc. 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.

Tep



Sealed With Printed Neckband For Your Protection


Active Ingredients



Eucalyptol, Menthol, Methyl salicylate, Thymol


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingvitis


Warnings



for this product


Do Not Use



if you have painful or swollen gums, pus from the fum 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 teaspoonfruls) between teeth for 30 seconds than 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 Informatin



cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).


Inactive Ingredients



water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.


Adverse Reaction



DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785   1-877-846-9949


Principal Display Panel



CAREONE

Compare to Original Listerine Antiseptic Mouthwash

ANTISEPTIC

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND THE GUM DISEASE GINGIVITIS

ORIGINAL FLAVOR

33.8 FL OZ (1.05 QT) 1 L


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