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 Strategic Sourcing 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.

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



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 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 manufactered or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.


Adverse Reactions



Another Quality Product Distributed by McKesson, One Post Street, San Francisco, CA 94104

Money Back Guarantee  www.healthmart.com/healthmartbrand

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Principal Display Panel



Compare to Original Listerine Antiseptic Mouthwash

Health Mart

Antiseptic

Mouthrinse

antigingivitis/antiplaque

Kills germs that cause bad breath, plaque and gingivitis gum disease

2X

DAY

PROTECTION   

Amber

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ


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