PRO Gel 5000 Citrus 5000 ug/g
Sodium fluoride · GEL, DENTIFRICE · DENTAL ALLIANCE HOLDINGS LLC
Pro Gel 5000 Citrus is a prescription fluoride gel used to help prevent tooth decay and strengthen tooth enamel. It contains sodium fluoride at a higher concentration than over-the-counter fluoride products.
Key Facts
- Brand Name
- PRO Gel 5000 Citrus
- Generic Name
- Sodium fluoride
- NDC Code (Product)
61578-216- Manufacturer
- DENTAL ALLIANCE HOLDINGS LLC
- Strength
- 5000 ug/g
- Dosage Form
- GEL, DENTIFRICE
- Route
- DENTAL
- Marketing Status
- Marketing Start
- 05/10/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications and Use: A dental caries preventive; for once daily self-applied topical use. It is well established that a 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 CariFree CTx4 Gel 5000 brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where 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: 1. After brushing with toothpaste, adults and pediatric patients 6 years of age and older, apply a thin ribbon of gel to the teeth with a toothbrush for at least one minute, preferably at bedtime. 2. Adult patients, expectorate gel after use. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.
Warnings
Warnings: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if water fluoridation exceeds 0.6 ppm. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Read directions carefully before using. Keep out of reach of infants and children.
Contraindications
Contraindications: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
Adverse Reactions: Allergic reactions and other idiosyncrasies have been rarely reported.
Frequently Asked Questions
What is PRO Gel 5000 Citrus used for?
Pro Gel 5000 Citrus is a prescription fluoride gel used to help prevent tooth decay and strengthen tooth enamel. It contains sodium fluoride at a higher concentration than over-the-counter fluoride products.
Is PRO Gel 5000 Citrus a controlled substance?
PRO Gel 5000 Citrus is not classified as a controlled substance by the DEA.
What is the generic name for PRO Gel 5000 Citrus?
The generic name for PRO Gel 5000 Citrus is Sodium fluoride. There are 12 other brand versions of Sodium fluoride.
What is the NDC code for PRO Gel 5000 Citrus 5000 ug/g?
The NDC (National Drug Code) for PRO Gel 5000 Citrus 5000 ug/g is 61578-216, listed by DENTAL ALLIANCE HOLDINGS LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)