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| Product NDC Code | 69968-0537 | ||||
|---|---|---|---|---|---|
| Drug Name | Listerine total care stain remover anticavity fluoride fresh mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 313029, 1798474 |
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| Application Number | part355 | ||||
| Labeler Name | Johnson & Johnson Consumer Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sorbitol, Alcohol (21.6% v/v), Hydrogen Peroxide, Poloxamer 407, Flavor, Sodium Saccharin, Sodium Lauryl Sulfate, Eucalyptol, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Disodium Phosphate, Sucralose
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 Stain Remover Anticavity Fluoride Fresh Mint Sodium Fluoride WATER SORBITOL ALCOHOL SODIUM LAURYL SULFATE POLOXAMER 407 HYDROGEN PEROXIDE PHOSPHORIC ACID EUCALYPTOL THYMOL METHYL SALICYLATE SACCHARIN SODIUM MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE 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 - 946 mL Bottle Label ANTICAVITY FLUORIDE MOUTHWASH LISTERINE ® TOTAL CARE STAIN REMOVER IMPORTANT: READ DIRECTIONS FOR PROPER USE SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION 6 IN 1 BENEFITS 1.HELPS PREVENT CAVITIES 2.RESTORES ENAMEL 3.STRENGTHENS TEETH 4.KILLS BAD BREATH GERMS 5.CLEANS THE WHOLE MOUTH 6.FRESHENS BREATH FRESH MINT 946 mL (32 Fl Oz) PRINCIPAL DISPLAY PANEL - 946 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
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)
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 oral irritation or tooth sensitivity occurs
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from excessive heat (40°C/104°F)
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 Stop use and ask a dentist if oral irritation or tooth sensitivity occurs 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