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| Product NDC Code | 55910-087 | ||||
|---|---|---|---|---|---|
| Drug Name | Rexall travel toothbrush and tooth-paste |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M021 | ||||
| Labeler Name | Old East Main CO. | ||||
| 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 & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing • Children under 2 years: ask a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG-32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (CI 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate
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 helps protect against cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Rexall Travel Toothbrush and Tooth-paste Sodium monofluorophosphate Rexall Cavity Protection Tooth-paste Sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL HYDRATED SILICA WATER POLYETHYLENE GLYCOL 1600 SODIUM LAURYL SULFATE GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TITANIUM DIOXIDE SODIUM PYROPHOSPHATE SODIUM BENZOATE BENZYL ALCOHOL SACCHARIN SODIUM SODIUM PHOSPHATE, TRIBASIC, 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.Packaging Old East Main -087
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
Conforms to airline carry-on regulations TO ASSEMBLE TOOTHBRUSH: Insert plug end of toothbrush into handle for use. Insert brush end of toothbrush into handle for storage. Visit us at : Rexall.com Since 1903 Rexall™ is a Trademark of Rexall Sundown, Inc. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 MADE IN INDIA
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 the reach of children under 6 yrs. of age. If more than used for brushing 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 1-866-4-REXALL
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 the reach of children under 6 yrs. of age. If more than used for brushing 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