Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 53942-072
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 53942-072). 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 you 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. It antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol {solution}, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3
Ada Statement
The ADA Council on Scientific Affairs Acceptance of Market Basket Spring Mint 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.
This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
Adverse Reactions
DISTRIBUTED BY:
DEMOULAS SUPER MARKETS, INC.
875 EAST STREET, TEWKSBURY, MA 01876
072.002/072AL
Principal Display Panel
MARKET
BASKET
MORE FOR YOUR DOLLAR
COMARE TO LISTERINE
ANTISEPTIC
MOUTH RINSE
Fresh Mint
ADA
Accepted
American
Dental
Association
Kills germs that cause BAd Breath, Plaque and the gum disease Gingivitis
Sealed With Printed Neckband For Your Protection
500 mL (16.9 FL OZ)
Image Description (Mm1)
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