Gel 1100

Description

Sodium Fluoride 0.24% is the active ingredient in this formulation. The product is presented as a gel in a 2.4 oz (68 g) tube. Inactive ingredients include Water, Xylitol, Hydrated Silica, Glycerin, Hydrogenated Starch Hydrolysate, Hydroxyethyl Cellulose, Sodium Lauryl Sulfate, Potassium Sorbate, Mentha Spicata (Spearmint) Leaf Oil, Hydroxyapatite, Polysorbate 20, Menthol, Sodium Saccharin, Sodium Benzoate, Sodium Bicarbonate, and Sodium Hydroxide. The formulation contains 25% Xylitol and features a Low Abrasion Formula with an Elevated pH.

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities).

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Healthcare professionals should be aware of the following critical information regarding the safe use of this product.

In the event of accidental ingestion exceeding the amount typically used for brushing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of the patient.

Currently, there are no specific warnings or general precautions outlined for this product. Additionally, no laboratory tests have been specified for monitoring purposes. However, healthcare providers should remain vigilant and exercise clinical judgment when advising patients on the use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies, and healthcare providers should be vigilant in assessing patients for these effects.

In addition to the common and serious adverse reactions, there are other important notes regarding additional adverse reactions that may arise during treatment. Postmarketing experiences have also contributed to the understanding of the safety profile of this medication, highlighting the need for ongoing surveillance and reporting of any new adverse events that may occur in the broader patient population.

Healthcare professionals are encouraged to report any adverse reactions to ensure comprehensive safety data is collected and analyzed.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Gel 1100 (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize swallowing, and they should be supervised as necessary until they are capable of brushing without assistance.

For infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication to ensure safety and efficacy. Prior to initiating therapy, it is essential to assess the creatinine clearance of patients with reduced kidney function. Additionally, regular renal function tests are recommended for those with existing kidney problems to monitor their condition effectively. Special monitoring is necessary for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light to maintain its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised. It is important to instruct children under 6 in proper brushing and rinsing techniques to minimize swallowing, with supervision provided until they are capable of using the product independently. For children under 2 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Gel 1100, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)