Pain Relief

Description

Safetec First Aid Oral Pain Relief is indicated for the fast relief of mouth sores, including canker sores, gum pain, toothache, and discomfort associated with dental work. The product is identified by NDC 61010-800-1 and is available for reorder under No. 53117. Reordering can be facilitated through various methods, including telephone at 1-800-456-7077, fax at 716-895-2969, or online at www.safetec.com.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with various oral conditions, including toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, gum sores, cheek bites, and denture irritation.

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

Dosage and Administration

Adults and children aged 2 years and older should dry the affected area before applying the medication undiluted. The medication may be used up to four times daily, with applications not exceeding every two hours, unless otherwise directed by a dentist or physician.

The use of this medication is not recommended for children under 2 years of age.

Contraindications

Use is contraindicated in the following situations:

• The product should not be used for teething.

• It is contraindicated in children under 2 years of age.

• Use for more than 7 days is contraindicated unless directed by a dentist or doctor.

• Exceeding the recommended dosage is contraindicated.

Warnings and Precautions

For oral use only; contact with eyes should be avoided.

Methemoglobinemia Warning The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This condition can manifest even in individuals who have previously used the product without issue. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy occur in the patient or a child under their care.

Allergy Alert This product should not be used by individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics. In the event of a skin reaction, the use of the product must be discontinued immediately, and medical assistance should be sought.

Overdose Information In the case of an overdose, it is imperative to seek medical help or contact a Poison Control Center without delay.

Monitoring and Follow-Up Patients should be advised to consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if irritation, pain, or redness persists or worsens, or if any swelling, rash, fever, or other allergic reactions develop, prompt medical evaluation by a doctor or dentist is recommended.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be vigilant for symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy. Immediate medical attention is required if any of these symptoms develop, as methemoglobinemia must be treated promptly.

Additionally, there is an allergy alert associated with this product. Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product is contraindicated for use in children under 2 years of age and should not be used for teething. Patients are advised not to use the product for more than 7 days unless directed by a dentist or doctor. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, fever, or other allergic reactions occur, patients should consult their healthcare provider promptly. It is also crucial not to exceed the recommended dosage.

In cases of overdose, patients should seek medical help or contact a Poison Control Center without delay.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics. Patients with such allergies should avoid this product to prevent potential allergic reactions.

In addition, the administration of this product may lead to the development of methemoglobinemia, a serious condition characterized by an abnormal increase in methemoglobin levels in the blood. This condition can significantly impair the oxygen-carrying capacity of hemoglobin, leading to reduced oxygen delivery to tissues. Prompt recognition and treatment of methemoglobinemia are essential to mitigate its effects. Monitoring for signs and symptoms of this condition is advised, particularly in patients who may be at higher risk.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this medication for teething. The product is contraindicated in children under 2 years of age. For children aged 2 years and older, the recommended application involves drying the affected area and applying the medication undiluted. It may be used up to 4 times daily, but not more frequently than every two hours, unless otherwise directed by a dentist or doctor.

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

The use of this product during pregnancy is not recommended. There is a potential risk of methemoglobinemia, a serious condition that can reduce the amount of oxygen carried in the blood, which may pose significant risks to both the pregnant patient and the developing fetus. Symptoms of methemoglobinemia include cyanosis (pale, gray, or blue colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy. If any of these symptoms occur, immediate medical attention should be sought.

This product is contraindicated in children under 2 years of age, and its use for teething is not advised. It is crucial to keep this product out of reach of children, and in the event of an overdose, medical help or contact with a Poison Control Center should be sought immediately. Additionally, the product should not be used if the packet is torn, cut, or opened, and it should be stored at room temperature between 15º to 30ºC (59º to 86ºF). Care should also be taken to avoid contact with the eyes.

Healthcare professionals should exercise caution and consider the potential risks when prescribing this product to pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this medication is not intended for use in teething and should not be administered to children under 2 years of age. Patients should also be cautioned against using the medication for more than 7 days unless specifically directed by a dentist or doctor.

Patients should be made aware that if symptoms of a sore mouth do not improve within 7 days, or if they experience persistent or worsening irritation, pain, or redness, they should consult their doctor or dentist without delay. Additionally, patients should be reminded not to exceed the recommended dosage to avoid potential adverse effects.

Storage and Handling

The product is supplied in packets that must be stored at room temperature, specifically within the range of 15º to 30ºC (59º to 86ºF). It is imperative that the integrity of the packaging is maintained; therefore, the product should not be used if the packet is torn, cut, or opened.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)