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 Family Dollar Services, 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 Salicylate 0.060%

Tymol 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 dentst 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 brushig 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 manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the distributor of Listerine.

DSP-TN-15000   DSP-MO-34   SDS-TN-15012


Adverse Reactions



DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

Not 100% satisfied? Return package and unused product within 30
days to any Family Dollar store for a refund (with receit) or exchange

Made in U.S.A. with U.S. and foreign components 

318.003/318AH


Principal Display Panel



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

NDC 55319-318-86

FAMILY

WELLNESS

COMPARE TO THE ACTIVE

INGREDENTS OF LISTERINE

100% SATISFACTION

OR YOUR MONEY BACK

GUARANTEED

Antiseptic

Mouth Rinse

Kills Germs That Cause

Bad Breath, Plaque and

The Gum Disease Gingivitis

1 L (33.8 FL OZ)


* Please review the disclaimer below.