PRO GEL 5000 MINT
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied: 2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus); NDC 61578-215-01 Pro Gel Mint Enclosure and Carton Labels CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint 2.4oz (68g) NDC 61578-215-01 Description: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Indications & usage: For once daily self-applied topical use as a dental caries preventive in adults and pediatric patients 6 years and older. Warnings: Not for systemic treatment. DO NOT SWALLOW. Read directions carefully before using. Keep out of reach of infants and children. Dosage & administration Follow these instructions unless otherwise instructed by your dental professional. Adults & pediatric patients 6 years of age or older: Apply a thin ribbon to a toothbrush. Brush daily for two minutes in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly. See package insert for further information. pH+ ® HAI NANO U.S. PATENTS NO. 9,427,384 and 10,143,633 Questions or comments? (800) 503-0625 or visit CariFree.com CariFree and pH+ are registered trademarks of Oral BioTech. Manufactured by Oral BioTech Albany, Oregon 97321 CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint NET WT 2.4 OZ (68 g) NDC 61578-215-01 CariFree PRO Gel 5000 is for adults and children to aid in the prevention of dental caries. PRO Gel 5000 is a neutral 1.1% sodium fluoride gel containing xylitol and nanoparticle hydroxyapatite at an elevated pH promote remineralization. Description Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Directions Use once daily as your normal dentifrice or as directed by your dental professional. Apply a thin ribbon of gel dentifrice to toothbrush and brush thoroughly on all tooth surfaces for at least one minute. Adults: expectorate gel after use and for best results do not eat, drink or rinse for 30 minutes. Adolescent patients, ages 6–17: expectorate after use and rinse mouth thoroughly. Instruct children under 12 to minimize swallowing. Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dental professional. Precautions: DO NOT SWALLOW. As with all medications, keep out of reach of infants and children. Store at controlled room temperature 20–25 degreesC (68–77 degreesF). See package insert for further information. CARIFREE ® Questions or comments? (800) 503-0625 or visit CariFree.com Manufactured by Oral BioTech Albany, Oregon 97321 3 61578 21501 3 Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint Prevents Cavities with 1.1% Sodium Fluoride Low Abrasion Formula Elevated pH 25% Xylitol pH+ ® nanoXIM Medical CariFree and pH+ are registered trademarks of Oral BioTech. U.S. Patents No. 9,427,384 and 10,143,633 Tube Mint Package Mint; NDC 61578-216-01 Pro Gel Citrus Enclosure and Carton Labels CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus 2.4oz (68g) NDC 61578-216-01 Description: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Indications & usage: For once daily self-applied topical use as a dental caries preventive in adults and pediatric patients 6 years and older. Warnings: Not for systemic treatment. DO NOT SWALLOW. Read directions carefully before using. Keep out of reach of infants and children. Dosage & administration Follow these instructions unless otherwise instructed by your dental professional. Adults & pediatric patients 6 years of age or older: Apply a thin ribbon to a toothbrush. Brush daily for two minutes in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly. See package insert for further information. pH+ ® HAI NANO U.S. PATENTS NO. 9,427,384 and 10,143,633 Questions or comments? (800) 503-0625 or visit CariFree.com CariFree and pH+ are registered trademarks of Oral BioTech. Manufactured by Oral BioTech Albany, Oregon 97321 CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus NET WT 2.4 OZ (68 g) NDC 61578-216-01 CariFree PRO Gel 5000 is for adults and children to aid in the prevention of dental caries. PRO Gel 5000 is a neutral 1.1% sodium fluoride gel containing xylitol and nanoparticle hydroxyapatite at an elevated pH promote remineralization. Description Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Directions Use once daily as your normal dentifrice or as directed by your dental professional. Apply a thin ribbon of gel dentifrice to toothbrush and brush thoroughly on all tooth surfaces for at least one minute. Adults: expectorate gel after use and for best results do not eat, drink or rinse for 30 minutes. Adolescent patients, ages 6–17: expectorate after use and rinse mouth thoroughly. Instruct children under 12 to minimize swallowing. Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dental professional. Precautions: DO NOT SWALLOW. As with all medications, keep out of reach of infants and children. Store at controlled room temperature 20–25 degreesC (68–77 degreesF). See package insert for further information. CARIFREE ® Questions or comments? (800) 503-0625 or visit CariFree.com Manufactured by Oral BioTech Albany, Oregon 97321 3 61578 21601 3 Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus Prevents Cavities with 1.1% Sodium Fluoride Low Abrasion Formula Elevated pH 25% Xylitol pH+ ® nanoXIM Medical CariFree and pH+ are registered trademarks of Oral BioTech. U.S. Patents No. 9,427,384 and 10,143,633 Tube Citrus Package Citrus
- How Supplied: 2 oz (56.699g) tube. NDC# 61578-205-01 (Mint) NDC# 61578-206-01 (Citrus)
- NDC 61578-215-01 Pro Gel Mint Enclosure and Carton Labels CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint 2.4oz (68g) NDC 61578-215-01 Description: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Indications & usage: For once daily self-applied topical use as a dental caries preventive in adults and pediatric patients 6 years and older. Warnings: Not for systemic treatment. DO NOT SWALLOW. Read directions carefully before using. Keep out of reach of infants and children. Dosage & administration Follow these instructions unless otherwise instructed by your dental professional. Adults & pediatric patients 6 years of age or older: Apply a thin ribbon to a toothbrush. Brush daily for two minutes in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly. See package insert for further information. pH+ ® HAI NANO U.S. PATENTS NO. 9,427,384 and 10,143,633 Questions or comments? (800) 503-0625 or visit CariFree.com CariFree and pH+ are registered trademarks of Oral BioTech. Manufactured by Oral BioTech Albany, Oregon 97321 CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint NET WT 2.4 OZ (68 g) NDC 61578-215-01 CariFree PRO Gel 5000 is for adults and children to aid in the prevention of dental caries. PRO Gel 5000 is a neutral 1.1% sodium fluoride gel containing xylitol and nanoparticle hydroxyapatite at an elevated pH promote remineralization. Description Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Directions Use once daily as your normal dentifrice or as directed by your dental professional. Apply a thin ribbon of gel dentifrice to toothbrush and brush thoroughly on all tooth surfaces for at least one minute. Adults: expectorate gel after use and for best results do not eat, drink or rinse for 30 minutes. Adolescent patients, ages 6–17: expectorate after use and rinse mouth thoroughly. Instruct children under 12 to minimize swallowing. Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dental professional. Precautions: DO NOT SWALLOW. As with all medications, keep out of reach of infants and children. Store at controlled room temperature 20–25 degreesC (68–77 degreesF). See package insert for further information. CARIFREE ® Questions or comments? (800) 503-0625 or visit CariFree.com Manufactured by Oral BioTech Albany, Oregon 97321 3 61578 21501 3 Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Mint Prevents Cavities with 1.1% Sodium Fluoride Low Abrasion Formula Elevated pH 25% Xylitol pH+ ® nanoXIM Medical CariFree and pH+ are registered trademarks of Oral BioTech. U.S. Patents No. 9,427,384 and 10,143,633 Tube Mint Package Mint
- NDC 61578-216-01 Pro Gel Citrus Enclosure and Carton Labels CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus 2.4oz (68g) NDC 61578-216-01 Description: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Indications & usage: For once daily self-applied topical use as a dental caries preventive in adults and pediatric patients 6 years and older. Warnings: Not for systemic treatment. DO NOT SWALLOW. Read directions carefully before using. Keep out of reach of infants and children. Dosage & administration Follow these instructions unless otherwise instructed by your dental professional. Adults & pediatric patients 6 years of age or older: Apply a thin ribbon to a toothbrush. Brush daily for two minutes in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly. See package insert for further information. pH+ ® HAI NANO U.S. PATENTS NO. 9,427,384 and 10,143,633 Questions or comments? (800) 503-0625 or visit CariFree.com CariFree and pH+ are registered trademarks of Oral BioTech. Manufactured by Oral BioTech Albany, Oregon 97321 CARIFREE ® PROFESSIONAL Rx Only Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus NET WT 2.4 OZ (68 g) NDC 61578-216-01 CariFree PRO Gel 5000 is for adults and children to aid in the prevention of dental caries. PRO Gel 5000 is a neutral 1.1% sodium fluoride gel containing xylitol and nanoparticle hydroxyapatite at an elevated pH promote remineralization. Description Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Directions Use once daily as your normal dentifrice or as directed by your dental professional. Apply a thin ribbon of gel dentifrice to toothbrush and brush thoroughly on all tooth surfaces for at least one minute. Adults: expectorate gel after use and for best results do not eat, drink or rinse for 30 minutes. Adolescent patients, ages 6–17: expectorate after use and rinse mouth thoroughly. Instruct children under 12 to minimize swallowing. Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dental professional. Precautions: DO NOT SWALLOW. As with all medications, keep out of reach of infants and children. Store at controlled room temperature 20–25 degreesC (68–77 degreesF). See package insert for further information. CARIFREE ® Questions or comments? (800) 503-0625 or visit CariFree.com Manufactured by Oral BioTech Albany, Oregon 97321 3 61578 21601 3 Pro Gel 5000 1.1% Neutral Sodium Fluoride Anti-Cavity Toothpaste Citrus Prevents Cavities with 1.1% Sodium Fluoride Low Abrasion Formula Elevated pH 25% Xylitol pH+ ® nanoXIM Medical CariFree and pH+ are registered trademarks of Oral BioTech. U.S. Patents No. 9,427,384 and 10,143,633 Tube Citrus Package Citrus
Overview
Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
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
: 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 & Precautions
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
: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
Allergic reactions and other idiosyncrasies have been rarely reported.
Storage & Handling
Storage: Store at controlled room temperature, 20-25° C (68-77°F)
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