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| Product NDC Code | 70683-0703 | ||||
|---|---|---|---|---|---|
| Drug Name | Dentisse |
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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 | Dentisse, 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 0.243%
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. 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 supevision. Children under 2 years of age, constult a dentist or a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients refined kaolin clay, purified water, sorbitol, vegetable glycerin, sodium laurly sulfate, cellulose gum, natural mint flavors, xylitol, bentonite clay, sodium citrate, sodium phosphate, sucralose
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.Uses Aids in the prevention of dental 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.Dentisse Sodium Fluoride KAOLIN BENTONITE SODIUM LAURYL SULFATE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE, DIBASIC XYLITOL SUCRALOSE MENTHOL SODIUM CITRATE
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 Panel DENTISSE ® Anticavity Fluoride Toothpaste Natural Clay Based Whitening Radiant Mint Net Wt. 3.2 oz. (91 g) Detisse_tube3.2_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.Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidently 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? Manufactured for Dentisse, Inc. 1-260-444-3046 Fort Wayne, IN 46825 www.dentisse.com
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.Other information For your protection, this tube has a foil seal under the cap.
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