Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 53942-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Super Markets, Inc for the product Antiseptic Mouth Rinse (NDC 53942-318). 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, keep out of reach of chrildren, 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 dentist immediately. These may be signs of periodtitis, a serious form of gum disease.
Stop Use And Ask A Dentist
gingivitis, bleeding, or redness persists for more than 2 weeks
Keep Out Of Reach Of Chrildren
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
Ada Council Statement
The ADA Council on Scientific Affairs Acceptance of Market Basket Antisept Mouth Rinse is based opn its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used at directed.
Disclaimer
This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine
Adverse Reaction
DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC.
875 EAST STREET
TEWKSBURY, MA 01876
MADE IN U.S.A.
318.003/318AH
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Compare to Listerine
ANTISEPTIC
MOUTH RINSE
Original
Kills germs that
cause Bad Breath,
Plaque and the gum
disease Gingivitis
ADA
Accepted
American Dental Association
Sealed With Printed Neckband For Your Protection
1 L (33.8 FL OZ)
Image Description (Mm3)
Image Description (Mm3)
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