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Listerine total care fresh mint anticavity - Medication Information

Product NDC Code 69968-0178
Drug Name

Listerine total care fresh mint anticavity

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
69968-0178-2 500 ml in 1 bottle, plastic (69968-0178-2)
69968-0178-3 95 ml in 1 bottle, plastic (69968-0178-3)
69968-0178-4 1000 ml in 1 bottle, plastic (69968-0178-4)
69968-0178-5 2 bottle, plastic in 1 package (69968-0178-5) / 1000 ml in 1 bottle, plastic
69968-0178-6 3 bottle, plastic in 1 package (69968-0178-6) / 1000 ml in 1 bottle, plastic
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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 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10mL (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 6 years of age: consult a dentist or 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, Eucalyptol, Flavor, Methyl Salicylate, Menthol, Phosphoric Acid, Sodium Saccharin, Thymol, Disodium Phosphate, Sucralose, Red 40, Blue 1

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 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 Total Care Fresh Mint Anticavity Sodium Fluoride WATER ALCOHOL SORBITOL POLOXAMER 407 PHOSPHORIC ACID EUCALYPTOL THYMOL METHYL SALICYLATE SACCHARIN SODIUM MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE FD&C RED NO. 40 FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION

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 - 500 mL Bottle Label ANTICAVITY FLOURIDE MOUTHWASH LISTERINE ® TOTAL CARE IMPORTANT: READ DIRECTIONS FOR PROPER USE. SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION 6 IN 1 BENEFITS HELPS PREVENT CAVITIES RESTORES ENAMEL STRENGTHENS TEETH KILLS BAD BREATH GERMS CLEANS THE WHOLE MOUTH FRESHENS BREATH 500 mL (16.9 Fl Oz) FRESH MINT PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

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 Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. Skillman, NJ 08558-9418

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 temporarily 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