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| Product NDC Code | 71927-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Orazen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | part356 | ||||
| Labeler Name | Orazen 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 Monofluorophosphate 0.76%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Orazen Orazen Inc Somerset, NJ 08873 Questions 888-349-7897 [email protected] Made in China/Hecho en China Fabrique en Chine
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 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015
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 prevent against cavities
Purpose
Information about the drug product’s indications for use.Purpose Anti-Cavity Toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Orazen SODIUM MONOFLUOROPHOSPHATE SORBITOL HYDRATED SILICA WATER POLYETHYLENE GLYCOL 400 CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE MICA SODIUM BENZOATE TRISODIUM PHOSPHIDE FD&C BLUE NO. 2 POTASSIUM SODIUM SACCHARATE 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.Ora-Zen Anticavity Toothpaste Bubblegum
Tube Art
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.
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: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.
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