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| Product NDC Code | 55873-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Oralline |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | part355 | ||||
| Labeler Name | J.M. Murray Center 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 Fluoride 0.24% w/w (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. Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor. Children under 6 years of age. Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, 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 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.OralLine Secure SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL HYDRATED SILICA WATER GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SACCHARIN SODIUM FD&C BLUE NO. 1 MINT FLAVOR OralLine SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL HYDRATED SILICA WATER GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SACCHARIN SODIUM TITANIUM DIOXIDE FD&C BLUE NO. 1 Mint Flavor
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.Product Labels OraLine Fluoride Toothpaste ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed No animal based ingredients. Mint Flavor Net Wt 3 oz (85 g) res Murray_oraline_fluoride Murray_oraline_fluoride_clear
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 Children under 2 years of age consult a doctor or a dentist Keep out of the 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