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| Product NDC Code | 0135-0577 | ||||
|---|---|---|---|---|---|
| Drug Name | Biotene |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M022 | ||||
| Labeler Name | Haleon US Holdings 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% (0.14% 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: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.
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.biotene sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL GLYCERIN CALCIUM PYROPHOSPHATE WATER HYDRATED SILICA XYLITOL SILICON DIOXIDE HYDROXYETHYL CELLULOSE, UNSPECIFIED ISOCETETH-20 XANTHAN GUM SODIUM BENZOATE CALCIUM LACTATE ANHYDROUS
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 NDC 0135-0577-01 biotene ® Fluoride Toothpaste SPECIALLY FORMULATED TO NOT IRRITATE Helps prevent cavities & strengthen teeth Gentle Formula GENTLE MINT NET WT 4.3 OZ (121.9g) 1000114 Front Carton Biotene Gentle Mint Original 4.3 oz (121.9g)
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.Additional information This product contains no Sodium Lauryl Sulfate (SLS) Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 @2019 GSK group of companies or its licensor. Questions or Comments? 1-800-922-5856
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 bushing 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 or comments? Call toll-free 1-800-922-5856
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, if irritation occurs discontinue use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at or below 25ºC (77ºF)
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 When using this product, if irritation occurs discontinue use. Keep out of reach of children under 6 years of age. If more than used for bushing 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