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| Product NDC Code | 61578-217 | ||||
|---|---|---|---|---|---|
| Drug Name | Gel 1100 grape |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | Dental Alliance 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 ingredients: Sodium Fluoride 0.24%
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 6 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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. 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: Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH), Hydroxyapatite, Hydroxyethyl Cellulose, Menthol (Mint only), Natural Flavors, Artificial Flavors (Citrus and Grape only) Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol
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 caries (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.Gel 1100 Mint sodium fluoride GLYCERIN HYDRATED SILICA MALTITOL TRIBASIC CALCIUM PHOSPHATE HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) MENTHOL POLYSORBATE 20 POTASSIUM SORBATE SACCHARIN SODIUM BENZOATE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE WATER XYLITOL SODIUM FLUORIDE FLUORIDE ION opaque Gel 1100 Citrus sodium fluoride GLYCERIN HYDRATED SILICA MALTITOL TRIBASIC CALCIUM PHOSPHATE HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) POLYSORBATE 20 POTASSIUM SORBATE SACCHARIN SODIUM BENZOATE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE WATER XYLITOL SODIUM FLUORIDE FLUORIDE ION opaque Gel 1100 Grape sodium fluoride GLYCERIN HYDRATED SILICA MALTITOL TRIBASIC CALCIUM PHOSPHATE HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) POLYSORBATE 20 POTASSIUM SORBATE SACCHARIN SODIUM BENZOATE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE WATER XYLITOL SODIUM FLUORIDE FLUORIDE ION opaque
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.Gel 1100 Mint, Citrus, and Grape enclosure and carton labels Box Principle Display Panel Box Principle Display Panel Box Principle Display Panel Tube Principle Display Panel Tube Principle Display Panel Tube Principle Display Panel
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.Warnings: 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.
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 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.
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