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Listerine clinical solutions enamel strength alpine mint - Medication Information

Product NDC Code 69968-0881
Drug Name

Listerine clinical solutions enamel strength alpine mint

Type Brand
Active Ingredients
Sodium fluoride .1 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 313029,
1798474
Application Number M021
Labeler Name Johnson & Johnson Consumer Inc.
Packages
Package NDC Code Description
69968-0881-1 1000 ml in 1 bottle (69968-0881-1)
69968-0881-5 500 ml in 1 bottle (69968-0881-5)
69968-0881-9 95 ml in 1 bottle (69968-0881-9)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

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: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing supervise children as necessary until capable of using without supervision Children under 12 years of age: consult a dentist or a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Flavor, Sodium Lauryl Sulfate, Eucalyptol, Sodium Saccharin, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Sucralose, Disodium Phosphate, Green 3, Yellow 10

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.
Uses aids in the prevention of dental cavities

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
Listerine Clinical Solutions Enamel Strength Alpine Mint Sodium Fluoride WATER ALCOHOL SORBITOL POLOXAMER 407 SODIUM LAURYL SULFATE PHOSPHORIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE SACCHARIN SODIUM FD&C GREEN NO. 3 EUCALYPTOL MENTHOL METHYL SALICYLATE SODIUM FLUORIDE FLUORIDE ION THYMOL D&C YELLOW NO. 10

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 DISPLAY PANEL - 1 L Bottle Label ANTICAVITY FLUORIDE MOUTHWASH LISTERINE ® CLINICAL SOLUTIONS † IMPORTANT: READ DIRECTIONS FOR PROPER USE SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION ENAMEL STRENGTH Repairs enamel and prevents cavities for stronger*, longer lasting teeth (*with brushing in a lab study) ALPINE MINT 1L (1 Qt 1.8 Fl Oz) Listerine_01

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.
Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call toll-free 888-222-0182 or 215-273-8755 (collect)

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature cold weather may cloud this product

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 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.

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