Oralline, Oralline Secure

Description

OraLine Fluoride Toothpaste is an American Dental Association (ADA) accepted product, recognized by the ADA Council on Scientific Affairs for its efficacy in preventing and reducing tooth decay when used as directed. This toothpaste is formulated without any animal-based ingredients and features a mint flavor. It is available in a net weight of 3 oz (85 g).

Uses and Indications

This drug is indicated for the protection against cavities and is effective in preventing and reducing tooth decay when used as directed.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, a pea-sized amount of toothpaste should be used. It is essential to instruct these children in proper brushing and rinsing techniques to minimize the risk of swallowing the toothpaste. Caregivers should supervise children during brushing until they are capable of performing the task independently.

Contraindications

Use is contraindicated in children under 2 years of age unless directed by a healthcare professional. Additionally, the product should be kept out of the reach of children under 6 years of age to prevent accidental ingestion or misuse.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a poison control center. This precaution is critical to ensure the safety and well-being of the patient. Healthcare professionals should advise patients on the importance of adhering to the recommended usage guidelines to prevent potential adverse effects associated with overconsumption.

Side Effects

Patients should be aware that in the event of accidental ingestion of an amount greater than that used for brushing, immediate medical assistance should be sought or a poison control center contacted. This warning is critical to ensure prompt intervention and minimize potential health risks associated with excessive consumption.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for patients to follow the recommended usage guidelines to avoid any adverse effects.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. For children under 6 years of age, a pea-sized amount of product should be used, and caregivers should instruct on proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance. For infants and children under 2 years of age, consultation with a doctor or dentist is recommended prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of ORALLINE sodium fluoride paste and gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when prescribing this product to women of childbearing potential.

Lactation

Lactating mothers should consult a doctor or dentist before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a poison control center or seek medical help without delay if more than the recommended amount for brushing has been ingested.

Symptoms of overdosage may vary, and prompt recognition is crucial for effective management. It is essential to monitor the patient closely for any adverse effects that may arise from excessive ingestion.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for the management of overdosage, which may involve gastric decontamination and monitoring of vital signs.

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 assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that children under 2 years of age should consult a doctor or a dentist before using this product. It is important to emphasize the necessity of professional guidance in this age group to ensure safety and appropriate use.

Additionally, healthcare providers should instruct patients to keep this product out of the reach of children under 6 years of age. This precaution is vital to prevent accidental ingestion or misuse, ensuring the safety of young children.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the product from freezing to maintain its integrity. When not in use, the tube should be kept tightly closed to prevent contamination or degradation. Any unused product should be discarded after the expiration date to ensure safety and efficacy.

Additional Clinical Information

Patients aged 2 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, a pea-sized amount of toothpaste should be used, and caregivers should instruct on proper brushing and rinsing techniques to minimize swallowing, supervising as necessary until the child can brush without assistance.

Clinicians should advise patients to seek medical help or contact a poison control center immediately if more than the recommended amount for brushing is swallowed. It is essential to keep the product out of reach of children, particularly those under 6 years of age, and to consult a doctor or dentist for children under 2 years.

Drug Information (PDF)

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

View product document (PDF)