PRO Gel 5000
Sodium fluoride · Gel, Dentifrice · Dental
Uses
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 and 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.
Contraindications
Contraindications: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
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.
Precautions
Precautions: General: Not for systemic treatments. DO NOT SWALLOW.
Side effects
Adverse Reactions: Allergic reactions and other idiosyncrasies have been rarely reported.
Pregnancy
Pregnancy: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood.
Pediatric use
Pediatric Use: The use of CariFree CTx4 Gel 5000 in pediatric age group 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to Contraindications and Warnings sections.
Overdosage
Overdosage: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nauseau, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (ie, less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (eg, milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (ie, more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (eg, milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (ie, more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of CariFree CTx4 Gel 5000 contains 2.5 mg fluoride. A 2 oz tube contains 284 mg fluoride.
Description
Description: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
How supplied
How Supplied: 2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus)
Storage
Storage: Store at controlled room temperature, 20-25° C (68-77°F)
Label text from the FDA structured product label by DENTAL ALLIANCE HOLDINGS LLC (revised Dec 29, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 2 products
PRO Gel 5000 NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 61578-215 | Sodium Fluoride 5000 ug/g Gel, Dentifrice | DENTAL ALLIANCE HOLDINGS LLC | UNAPPROVED DRUG OTHER |
| 61578-216 | Sodium Fluoride 5000 ug/g Gel, Dentifrice | DENTAL ALLIANCE HOLDINGS LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is PRO Gel 5000 used for?
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…
What are the side effects of PRO Gel 5000?
Adverse Reactions: Allergic reactions and other idiosyncrasies have been rarely reported. See the full label for the complete list.
Who makes PRO Gel 5000?
PRO Gel 5000 is listed by 1 labeler in the FDA NDC directory, including DENTAL ALLIANCE HOLDINGS LLC.