Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl saliclate 0.060%
Thymol 0.064%
Antiseptic Mouthwash
FDA Label NDC 50804-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perrigo Direct, Inc for the product Antiseptic (NDC 50804-318). 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 gun line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serous 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
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 teaspoonsfuls) 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 properites 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 Reactions Section
Distributed by
Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269
1-866-696-0957 www.valuelabels.com
318.003/318AH
Principal Display Panel
GoodSense
NDC 5084-318-69
Sealed With Printed Neckband For Your Protection
Antiseptic Mouth Rinse
Original
Kills Germs That Cause
Bad Breath, Plaque & The Gum Disease Gingivitis
ADA Accepted American Dental Association
“The ADA Council on Scientific Affairs’ Acceptance of Good Sense Original Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.”
Compare to active ingredients of Listerine
1 Liter (33.8 FL OZ)
Image Description (Mm3)
Image Description (Mm3)
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