Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Tymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 55319-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Stores, Inc for the product Antiseptic Mouth Rinse (NDC 55319-318). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Image Description (Mm3)
Image Description (Mm3)
* Please review the disclaimer below.
