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Rite Aid Tooth and Gum Pain Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Benzocaine 10 g/100 g
Other brand names
Dosage form
Strip
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
January 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 10 g/100 g
Other brand names
Dosage form
Strip
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
January 11, 2023
Manufacturer
Rite Aid
Registration number
part356
NDC root
11822-6035
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

RITE AID® PHARMACY Medicated Tooth & Gum Pain Relief Cushions are designed to provide immediate relief from toothache pain. Each gel cushion contains 10% benzocaine, which is an oral pain reliever that soothes and comforts the affected area. This product is specifically indicated for the temporary relief of pain caused by toothaches, helping you feel more comfortable during discomfort.

Available in packs of eight gel cushions, each weighing 0.5 grams, these cushions are a convenient option for managing tooth pain when you need quick relief.

Uses

If you're experiencing a toothache, this medication can provide you with temporary relief from the pain. It's designed specifically to help ease the discomfort associated with dental issues, allowing you to go about your day with less interruption.

Rest assured, this medication does not have any known teratogenic effects, which means it is not expected to cause harm to a developing fetus if taken during pregnancy.

Dosage and Administration

To use the gel cushion effectively, start by carefully removing it from its packaging. Gently mold the cushion with your fingers until it becomes soft. Once it's ready, apply it to the affected area of your tooth or gum, pressing it gently for about 5 to 10 seconds to ensure a comfortable fit. The gel cushion will stay in place and will dissolve slowly in your mouth.

If you are an adult or a child aged 12 years and older, you can use the gel cushion up to three times a day, or as directed by your dentist or doctor. For children under 12 years old, it's important to consult with a dentist or doctor before use. Additionally, do not use this product for children under 2 years of age.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not use it for more than 7 days unless your dentist or doctor advises you to do so. Additionally, avoid using it for teething relief and do not give it to children under 2 years of age. Always follow the directions provided to prevent any potential issues.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you've used the product before. If you or a child experiences symptoms like pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, if you have a history of allergies to local anesthetics (like procaine or benzocaine), you should avoid this product. You should also consult a doctor if you notice swelling, rash, or fever, if irritation or pain persists or worsens, if symptoms do not improve within 7 days, or if you experience any allergic reactions.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

You should also avoid this product if you have a known allergy to local anesthetics like procaine, butacaine, or benzocaine. If you notice any swelling, rash, fever, or if irritation, pain, or redness persists or worsens, stop using the product and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you experience an allergic reaction, reach out to your healthcare provider for guidance. In case of an overdose, seek medical assistance or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware of certain precautions regarding the use of this product. It is not recommended for children under 2 years of age. One significant warning to consider is the risk of methemoglobinemia, a serious condition that can reduce the amount of oxygen in the blood. This risk exists even if you have used the product before, so it's crucial to monitor for any unusual symptoms.

If you experience swelling, rash, fever, or if irritation, pain, or redness persists or worsens, you should stop using the product and consult your doctor. Additionally, if symptoms do not improve within 7 days or if you have an allergic reaction, seek medical advice immediately. Always keep this product out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center right away.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to be cautious when considering this medication for your child. If your child is under 2 years old, you should not use this medication at all. For children between the ages of 2 and 12, it's best to consult with a dentist or doctor before giving it to them. This ensures that the medication is safe and appropriate for their specific needs. Always prioritize your child's health by seeking professional advice when it comes to their medication.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of potential interactions when using this product. If you have a history of allergies to local anesthetics, such as procaine, butacaine, or benzocaine (often ending in “caine”), you should avoid using this product. Additionally, this product may lead to a serious condition called methemoglobinemia, which affects how oxygen is carried in your blood.

Always discuss any medications or tests with your healthcare provider to ensure your safety and to understand how they may interact with your current health conditions or treatments. Your provider can help you navigate these concerns effectively.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15-30°C (59-86°F). This temperature range helps maintain its effectiveness. Before using the product, check the blister card; do not use it if the card is broken, as this could compromise the safety and integrity of the device.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can apply this medication topically, which means you will put it directly on the skin. For adults and children aged 12 and older, you can use it up to three times a day or as your dentist or doctor advises. If your child is under 12, it's best to consult with a dentist or doctor before use. Additionally, do not use this medication on children younger than 2 years old.

FAQ

What is RITE AID® PHARMACY Medicated Tooth & Gum Pain Relief Cushions used for?

It is used for the temporary relief of pain due to toothaches.

What active ingredient is in RITE AID® PHARMACY Medicated Tooth & Gum Pain Relief Cushions?

It contains benzocaine 10%, which acts as an oral pain reliever.

How should I use the gel cushions?

Carefully remove a gel cushion from the blister, mold it until soft, apply it to the affected area, and press gently for 5-10 seconds.

Who can use this product?

Adults and children 12 years of age and older can use it up to 3 times daily. Children under 12 should consult a dentist or doctor, and it should not be used in children under 2 years of age.

Are there any warnings associated with this product?

Yes, it may cause methemoglobinemia, a serious condition. Seek immediate medical attention if you experience symptoms like pale skin, headache, or shortness of breath.

What should I do if I experience an allergic reaction?

Stop using the product and seek medical help if you develop swelling, rash, or fever.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before use, as there is potential for excretion in breast milk.

How should I store RITE AID® PHARMACY Medicated Tooth & Gum Pain Relief Cushions?

Store at room temperature between 15-30°C (59-86°F) and do not use if the blister card is broken.

Packaging Info

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

Packaging configurations for Rite Aid Tooth and Gum Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

RITE AID® PHARMACY Medicated tooth and gum pain relief cushions contain benzocaine 10% as the active ingredient, serving as an oral pain reliever. Each package includes eight gel cushions, with each cushion weighing 0.5 g. These cushions are designed to provide immediate pain relief while soothing and comforting the affected areas.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches.

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

Dosage and Administration

Carefully remove the gel cushion from the blister pack. Gently mold the cushion with fingers until it becomes soft. The molded gel cushion should be applied to the affected tooth or gum area, ensuring it is pressed gently for 5 to 10 seconds to achieve a comfortable fit. The gel cushion will remain in place and dissolve slowly in the mouth.

For adults and children aged 12 years and older, the gel cushion may be used up to three times daily or as directed by a dentist or doctor. For children under 12 years of age, it is recommended to consult a dentist or doctor before use. The gel cushion should not be used in children under 2 years of age.

Contraindications

Use is contraindicated in the following situations:

  • Do not exceed the recommended dosage.

  • Do not use for periods longer than 7 days unless directed by a healthcare professional.

  • Do not administer for teething relief.

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

Warnings and Precautions

The use of this product carries significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Methemoglobinemia Warning This product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms can manifest even in patients who have previously used the product without incident. Immediate cessation of use and prompt medical attention are imperative if any of the following symptoms occur in the patient or a child under their care: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Allergy Alert Healthcare professionals should advise patients against using this product if they have a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics.

Monitoring and Follow-Up Patients should be instructed to discontinue use and consult a physician if any of the following conditions arise: swelling, rash, or fever; persistent or worsening irritation, pain, or redness; lack of improvement in symptoms after 7 days; or any signs of an allergic reaction.

Emergency Medical Assistance In the event of an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately. Prompt intervention is essential to mitigate potential adverse effects.

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. This serious condition requires prompt treatment and can occur even in patients who have previously used the product without issue. Patients should discontinue use and seek immediate medical attention if they or a child in their care experience 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.

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.

Patients are advised to stop use and consult a healthcare professional if they experience swelling, rash, or fever; if irritation, pain, or redness persists or worsens; if symptoms do not improve within 7 days; or if any allergic reaction occurs.

Drug Interactions

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

Additionally, the product carries a warning regarding the risk of methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. It is essential for healthcare providers to monitor patients for signs of methemoglobinemia, as prompt treatment is necessary to address this condition effectively.

Packaging & NDC

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

Packaging configurations for Rite Aid Tooth and Gum Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. For children aged 2 to 11 years, it is recommended to consult a dentist or doctor prior to use to ensure safety and appropriateness of treatment.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the use of this product is contraindicated in children under 2 years of age. There is a warning regarding the potential risk of methemoglobinemia associated with this product, a serious condition that can significantly reduce the amount of oxygen carried in the blood. This adverse effect may occur even in patients who have previously used the product without incident.

Healthcare professionals should advise pregnant patients to discontinue use and seek medical attention if they experience swelling, rash, fever, persistent or worsening irritation, pain, or redness. Additionally, if symptoms do not improve within 7 days or if any allergic reactions occur, medical consultation is recommended.

It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 patients 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the oxygen-carrying capacity of blood and may occur even in individuals who have previously used the product without incident.

Healthcare professionals and patients are advised to discontinue use and seek immediate medical attention 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 develop.

Additionally, it is noted that individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

Patients should be informed not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless directed by a dentist or doctor. It is important to emphasize that this medication should not be used for teething and is contraindicated in children under 2 years of age.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience swelling, rash, or fever. Additionally, patients should be advised to stop using the medication and seek medical advice if irritation, pain, or redness persists or worsens, or if symptoms do not improve within 7 days. Patients should also be made aware to stop use and contact a doctor if any signs of an allergic reaction occur.

Storage and Handling

The product is supplied in a blister card format. Each blister card must be inspected prior to use; do not use if the blister card is broken.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 15-30°C (59-86°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, it may be used up to three times daily or as directed by a dentist or doctor. For children under 12 years of age, consultation with a dentist or doctor is recommended prior to use. The product is not to be used in children under 2 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Rite Aid Tooth and Gum Pain Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.