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Antiseptic mouth rinse - Medication Information

Product NDC Code 71141-157
Drug Name

Antiseptic mouth rinse

Type Brand
Active Ingredients
Eucalyptol .92 mg/ml
Menthol .42 mg/ml
Methyl salicylate .6 mg/ml
Thymol .64 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 1043619
Application Number part356
Labeler Name Lidl US, LLC
Packages
Package NDC Code Description
71141-157-12 1500 ml in 1 bottle, plastic (71141-157-12)
71141-157-32 1000 ml in 1 bottle, plastic (71141-157-32)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use helps control plaque that leads to gingivitis

Purpose

Information about the drug product’s indications for use.
Purpose Antigingivitis, Antiplaque

Spl product data elements

Usually a list of ingredients in a drug product.
Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL BENZOIC ACID POLOXAMER 407 SODIUM BENZOATE CARAMEL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Panel Display dentaux by LIDL ORIGINAL ANTI-GINGIVITIS/ANTI-PLAQUE MOUTHWASH ANTISEPTIC MOUTHWASH ADA ACCEPTED American Dental Association Helps prevent and redice plaque Helps prevent and redice gingivitis SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION Kills Germs that Cause Plaque, Gingivitis, Bad Breath NDC-71141-157-12 50.7 FL OZ (1.58 QT) 1.5L image description

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
*This product is not manufactued or distributed by Johnson & Johnson Corporation., owner of the registered trademark Listerine. DISTRIBUTED BY Lidl US, LLC Arlington, VA 22202 QUESTIONS? 1-844-5071 www.Lidl.com LIDL Love it! Guarantee money refunded item replaced DSP-TN-21091 DSP-MO-20087 save water.lidl Discard seal, empty & Replace Cap Plastic bottle how2recycle.info Principal Panel Display SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION Kills Germs That Cause Bad Breath, Plaque, & Gingivitis Gum Disease ANTISEPTIC MOUTHWASH ORIGINAL AMBER ADA ACCEPTED American Dental Association Helps reduce plaque Helps reduce gingivitis Compare to Original Listerine Antiseptic Mouthwash ANTI-GINGIVITIS/ANTI-PLAQUE MOUTHWASH 1.0 L (1 QT 1.8 FL OZ) image description

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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 periodontitis, a serious form of gum disease.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-844-344-5071

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For this product

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API