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Oralabs Cold Sore Treatment

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This product has been discontinued

Active ingredient
Benzocaine 5.00 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
September 4, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5.00 mg/1 g
Other brand names
Dosage form
Ointment
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 2014
Label revision date
September 4, 2014
Manufacturer
OraLabs
Registration number
part348
NDC root
63645-162
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

This medication is used to treat cold sores and fever blisters that appear on the face and lips. Cold sores are caused by the herpes simplex virus, and this treatment helps to alleviate the symptoms associated with these outbreaks.

If you experience cold sores, this medication can provide relief and support your healing process. It's important to follow the guidance provided by your healthcare professional for the best results.

Uses

If you're dealing with cold sores or fever blisters on your face and lips, this medication can help treat those uncomfortable outbreaks. Cold sores are caused by the herpes simplex virus, and they often appear as small, painful blisters. Using this treatment can help reduce the duration and severity of your symptoms, allowing you to feel more comfortable and get back to your daily activities more quickly.

Dosage and Administration

When using this cream, you should apply it to the affected area no more than four times a day. If you are treating a child who is under 2 years old, it’s important to consult a physician (doctor) before use.

To apply the cream, gently rub it into the skin until it is clear. Remember to wash your hands both before and after applying the cream to keep the area clean and to avoid spreading the medication to other areas.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. This ensures your safety and well-being.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always follow the guidance provided to ensure safe use.

Side Effects

When using this product, it's important to be aware of potential side effects and warnings. This product is for external use only, so avoid applying it to your eyes or large areas of your body. If you have deep or puncture wounds, animal bites, or serious burns, please consult a physician. Additionally, if you are allergic to any of the ingredients, do not use this product.

While using it, be cautious to avoid contact with your eyes, and follow the directions carefully. If your condition worsens or does not improve after one week, stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or on large areas of your body. If you have deep or puncture wounds, animal bites, or serious burns, it's important to consult a physician. Be cautious if you have allergies to any of the ingredients in this product, and always use it as directed. If you notice that your condition worsens, stop using the product and contact your doctor. Additionally, do not use it for more than one week unless your doctor advises you to do so.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

Currently, there is no information available about the use of Oralabs Cold Sore Treatment (benzocaine ointment) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication to the affected area up to four times a day. However, if your child is under 2 years old, you should consult a physician (doctor) before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help determine the best course of action based on your individual needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best use of your product, store it at room temperature, away from direct sunlight and moisture. It's important to keep it out of reach of children to prevent accidental ingestion or misuse. Additionally, please remember not to share this product with anyone, as it is intended for your personal use only. Following these guidelines will help maintain safety and effectiveness.

Additional Information

You should apply this topical medication to the affected area no more than four times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a physician before use. Always wash your hands before and after applying the cream to ensure cleanliness.

In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Remember, do not share this product with anyone to avoid potential misuse.

FAQ

What is this drug used for?

This drug is used for the treatment of cold sores and fever blisters on the face and lips.

How should I apply this medication?

You should apply it to the affected area not more than 4 times daily if you are an adult or a child 2 years of age and older. For children under 2 years, consult a physician.

What should I do if I accidentally swallow this medication?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and do not use on large areas of the body. Consult a physician for deep wounds, animal bites, or serious burns.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition gets worse. Do not use it longer than 1 week unless directed by a doctor.

How should I store this medication?

Store at room temperature and keep out of reach of children. Do not share this product with anyone.

Is there any information regarding use during pregnancy or nursing?

There is no specific information provided regarding use during pregnancy or by nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Oralabs Cold Sore Treatment (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oralabs Cold Sore Treatment.
Details

Drug Information (PDF)

This file contains official product information for Oralabs Cold Sore Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by SPL Code 34089-3 and consists of a combination of active and inactive ingredients. The active ingredient is insert active ingredient name here. Inactive ingredients include insert inactive ingredients here. This formulation is presented in insert dosage form, e.g., tablet, liquid, etc.. The physical characteristics of the product are insert physical characteristics, e.g., color, shape, size, etc..

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters located on the face and lips.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than four times daily. It is important to rub the cream in gently, as it applies clear.

For children under 2 years of age, it is advised to consult a physician prior to use.

Healthcare professionals should instruct patients to wash their hands thoroughly before and after applying the cream to ensure proper hygiene and minimize the risk of contamination.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

Warnings and Precautions

For external use only; this product should not be applied to the eyes or over large areas of the body. In cases of deep or puncture wounds, animal bites, or serious burns, it is imperative to consult a physician prior to use.

An allergy alert is warranted; individuals should refrain from using this product if they have a known allergy to any of its ingredients. While using this product, it is crucial to avoid contact with the eyes and to adhere strictly to the directions provided.

Should the condition worsen during use, it is essential to discontinue use and consult a healthcare professional. The product should not be used for longer than one week unless specifically directed by a physician.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should not be applied to the eyes or over large areas of the body. In cases of deep or puncture wounds, animal bites, or serious burns, it is advised to consult a physician prior to use.

Additionally, individuals with known allergies to any of the ingredients in this product should refrain from using it. While using this product, patients should avoid contact with the eyes and adhere strictly to the directions provided.

If the condition being treated worsens, patients are instructed to discontinue use and seek medical advice. Furthermore, it is recommended that this product not be used for longer than one week unless directed by a healthcare professional.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Oralabs Cold Sore Treatment (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oralabs Cold Sore Treatment.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to four times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

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

There is currently no information available regarding the use of Oralabs Cold Sore Treatment (benzocaine ointment) during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals should exercise caution and consider the absence of data when advising women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring of these patients.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 for guidance. Emphasizing the importance of prompt action in such situations can help ensure patient safety and appropriate care.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Additionally, the product should not be shared with anyone to ensure safety and proper use.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients on the importance of seeking immediate medical assistance or contacting a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients are also advised not to share the product and to wash their hands before and after application to ensure safety and hygiene.

Drug Information (PDF)

This file contains official product information for Oralabs Cold Sore Treatment, 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 Oralabs Cold Sore Treatment, 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.

Learn more in our Editorial Policy

Last AI update:

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.