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| Product NDC Code | 69968-0701 | ||||
|---|---|---|---|---|---|
| Drug Name | Listerine essential care |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M022 | ||||
| Labeler Name | Kenvue Brands LLC | ||||
| 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 monofluorophosphate 0.76% (0.13% 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 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician. children 2-6 years use a pea sized amount instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. children under 2 years of age: ask a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, 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.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 Essential Care Sodium Monofluorophosphate WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 1600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM EUCALYPTOL METHYL SALICYLATE THYMOL PHOSPHORIC ACID MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE XANTHAN GUM BENZOIC ACID SPEARMINT OIL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 D&C YELLOW NO. 10 SODIUM MONOFLUOROPHOSPHATE 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 - 119 g Tube Carton LISTERINE ® ESSENTIAL CARE ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL FRESHENS BREATH THE LISTERINE ® WAY POWERFULL MINT GEL Kills the Germs that Cause Bad Breath Helps Prevent Cavities Removes Stains NET WT 4.2 OZ. (119 g) 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 under 6 years of age. If more than used for brushing is accidently 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.
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 under 6 years of age. If more than used for brushing is accidently 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