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| Product NDC Code | 73051-0754 | ||||
|---|---|---|---|---|---|
| Drug Name | Orthocare |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | M021 | ||||
| Labeler Name | Orthosciences, 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.Inactive Ingredient Sodium Fluoride 0.24% (0.15% 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: Use a pea sized amount and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children's brushing until good habits are established. Children under 2 years: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Lysine, Arginine, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose Gum, Alanine, Sodium Benzoate, Disodium Phospate, Sodium Saccharin, FD&C Blue #1
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.Orthocare Sodium Fluoride ALANINE SODIUM PHOSPHATE DIBASIC DIHYDRATE GLYCERIN SORBITOL POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM SACCHARIN SODIUM BENZOATE MINT HYDRATED SILICA SODIUM FLUORIDE FLUORIDE ION WATER FD&C BLUE NO. 1 TITANIUM DIOXIDE ARGININE LYSINE SODIUM LAURYL PHOSPHATE
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 OrthoSciences™ ORTHOCARE Specially formulated for those with braces NET WT. 4.4 OZ. (125 grams) Anticavity Fluoride Toothpaste orthocare_toothpaste_image.jpg
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 accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: For your protection, this tube has a foil seal under the cap.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-833-261-0246
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
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