Sodium fluoride .22 g/100g
Toothpaste · CREAM · DUKAL LLC
Sodium fluoride is a cream containing toothpaste at .22 g/100g, taken oral. Manufactured by DUKAL LLC.
Key Facts
- Brand Name
- Sodium fluoride
- Generic Name
- Toothpaste
- NDC Code (Product)
65517-2000- Manufacturer
- DUKAL LLC
- Strength
- .22 g/100g
- Dosage Form
- CREAM
- Route
- ORAL
- Marketing Status
- Application #
- M022
- Marketing Start
- 11/13/2013
Recall History
Ecometics, Inc.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Dental Alliance Holdings LLC
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings LLC
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Haleon US Holdings LLC
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Dental Alliance Holdings LLC
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings LLC
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
AVKARE LLC
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Dental Alliance Holdings LLC
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Dosage & Administration
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (morning and evening) or as recommended by dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age:consultant a dentist or physician.
Warnings
WARNINGS: Not for systemic treatment- Do not Swallow. Keep out of the reach of children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Contraindications
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Adverse Reactions
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Sodium fluoride used for?
Sodium fluoride contains Toothpaste. It is a cream taken oral. Consult your doctor for specific uses.
Is Sodium fluoride a controlled substance?
Sodium fluoride is not classified as a controlled substance by the DEA.
What is the generic name for Sodium fluoride?
The generic name for Sodium fluoride is Toothpaste. There are 4 other brand versions of Toothpaste.
What is the NDC code for Sodium fluoride .22 g/100g?
The NDC (National Drug Code) for Sodium fluoride .22 g/100g is 65517-2000, listed by DUKAL LLC.