ADD CONDITION
Maximum Strength Cold Sore Treatment
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This product has been discontinued
- Active ingredients
- Petrolatum 892 mg/1 g
- Phenol 15 mg/1 g
- Menthol, Unspecified Form 10 mg/1 g
- Camphor (synthetic) 30 mg/1 g
- Other brand names
- Dosage form
- Gel
- 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
- November 14, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Petrolatum 892 mg/1 g
- Phenol 15 mg/1 g
- Menthol, Unspecified Form 10 mg/1 g
- Camphor (synthetic) 30 mg/1 g
- Other brand names
- Dosage form
- Gel
- 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
- November 14, 2024
- Manufacturer
- Target Corporation
- Registration number
- M017
- NDC root
- 11673-412
- Drug Information (PDF)
- Prescribing information, PDF file
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 product is a maximum strength formulation designed to treat cold sores and fever blisters on the face or lips. It contains active ingredients like camphor, menthol, and phenol, which work on contact to provide temporary relief from itching and pain associated with these conditions. Additionally, it acts as a skin protectant, helping to shield minor cuts, scrapes, burns, and sores, while also preventing and protecting chapped or cracked skin and lips.
You can apply this treatment up to three times daily, and it is paraben-free, ensuring a gentle approach for your skin. The clear application makes it easy to use without leaving a noticeable residue.
Uses
If you're dealing with cold sores or fever blisters on your face or lips, this treatment can help. It not only works to treat these sores but also provides temporary relief from the itching and pain that often accompany them.
Additionally, this product can protect minor cuts, scrapes, burns, and sores, offering a barrier to help keep them safe while they heal. If you suffer from chapped or cracked skin and lips, it can also help prevent and temporarily protect those areas, keeping your skin more comfortable.
Dosage and Administration
To use this product effectively, start by cleaning the affected area thoroughly. Then, apply a small amount of the cream directly to the area that needs treatment. You can do this 1 to 3 times each day, gently rubbing it in to ensure it absorbs well. If desired, you may cover the area with a sterile bandage to protect it.
Remember to wash your hands both before and after applying the cream to keep everything clean. It's important not to share this product with anyone else, as it is meant for your personal use. If you are considering using this cream for a child under 12 years old, be sure to consult a doctor first.
What to Avoid
It's important to use this medication responsibly. You should not take it for longer than one week unless your doctor specifically instructs you to do so. Additionally, be careful to avoid any contact with your eyes, as this could lead to irritation or other issues.
While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and well-being. Always consult your healthcare provider if you have any questions or concerns.
Side Effects
When using this product, it's important to avoid contact with your eyes and to use it only as directed. If you notice that your condition persists or worsens, stop using the product and consult a doctor. You should not use it for more than one week unless your doctor advises you to do so.
Additionally, this product is for external use only and should not be applied to large areas of the body or used on deep wounds, animal bites, or serious burns without consulting a physician. If you are allergic to any of the ingredients, do not use it. Keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.
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. Additionally, do not use this product if you are allergic to any of its ingredients.
Be cautious to avoid contact with your eyes and use the product only as directed. If your condition does not improve or worsens after using it, stop using the product and consult your doctor. You should not use it for more than one week unless your doctor advises you to do so.
If you accidentally swallow the product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.
Overdose
If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.
Signs of an overdose may include unusual symptoms, which can vary depending on the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Always prioritize safety and act quickly in these situations.
Pregnancy Use
When considering the use of MAXIMUM STRENGTH COLD SORE TREATMENT during pregnancy, it's important to note that the product insert does not provide specific warnings, precautions, or dosage adjustments for pregnant individuals. Additionally, there is no information indicating whether the product is contraindicated (not recommended) during pregnancy or if it poses any risks to the developing fetus.
Since there are no stated safety concerns regarding the use of this treatment while pregnant, you may feel reassured. However, it's always best to consult with your healthcare provider before using any medication during pregnancy 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.
As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.
Pediatric Use
If you have a child under 12 years old, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional advice when it comes to their medication.
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, it’s important to consult with a healthcare provider for personalized advice. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary adjustments to your medications.
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).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.
Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.
Storage and Handling
To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.
Additional Information
No further information is available.
FAQ
What is the maximum strength formulation used for?
It is used for the treatment of cold sores and fever blisters on the face or lips.
What are the active ingredients in this product?
The active ingredients include camphor (3.00%), menthol (1.00%), phenol (1.50%), and white petrolatum (89.20%).
How should I apply this product?
Clean the affected area and apply a small amount to the area 1 to 3 times daily, rubbing it in gently.
What precautions should I take when using this product?
Avoid contact with eyes and do not use over large areas of the body. Consult a physician for deep or puncture wounds, animal bites, or serious burns.
What should I do if the condition persists or worsens?
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
Is this product safe for children?
Children under 12 years of age should ask a doctor before use.
What should I do if I accidentally swallow this product?
Get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Can I use this product during pregnancy or while nursing?
There are no specific warnings or recommendations regarding use during pregnancy or lactation provided in the insert.
How should I store this product?
Store at room temperature.
Packaging Info
Below are the non-prescription pack sizes of Maximum Strength Cold Sore Treatment (camphor, menthol, phenol, white petrolatum). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Gel |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Maximum Strength Cold Sore Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
This formulation contains Camphor (3.00%), Menthol (1.00%), and Phenol (1.50%) as active ingredients, combined with White Petrolatum (89.20%) as the primary inactive ingredient. It is designed for the treatment of cold sores and fever blisters, serving as a skin protectant that provides temporary relief from pain and discomfort upon contact. The product is clear upon application and is free from parabens. Each container has a net weight of 0.07 ounces (2.0 grams) and is intended for application up to three times daily.
Uses and Indications
This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It provides temporary relief from the symptoms of itching and pain associated with these conditions. Additionally, this drug temporarily protects minor cuts, scrapes, burns, and sores, and helps prevent and temporarily protects chapped or cracked skin and lips.
There are no teratogenic or nonteratogenic effects mentioned in the available data.
Dosage and Administration
The affected area should be cleaned prior to application. A small amount of the product is to be applied to the affected area 1 to 3 times daily, ensuring that it is rubbed in gently. If desired, the area may be covered with a sterile bandage following application.
Healthcare professionals are advised to instruct patients to wash their hands before and after applying the cream to maintain hygiene. It is important to emphasize that this product should not be shared with others. For patients under 12 years of age, consultation with a physician is recommended prior to use.
Contraindications
Use is contraindicated in patients who require treatment for longer than one week without medical supervision. Prolonged use may lead to unforeseen complications. Additionally, contact with the eyes should be strictly avoided due to the potential for irritation or injury.
Warnings and Precautions
For external use only; this product should not be applied to the eyes or over large areas of the body. In the event of deep or puncture wounds, animal bites, or serious burns, it is imperative to consult a physician for appropriate medical evaluation and treatment.
Healthcare professionals should be aware of the allergy alert associated with this product. It is contraindicated for individuals with known allergies to any of its ingredients.
General precautions include avoiding contact with the eyes and adhering strictly to the usage instructions provided.
Patients should be advised to discontinue use and seek medical consultation if the condition persists or worsens. The product should not be used for longer than one week unless directed by a healthcare provider.
In cases of accidental ingestion, immediate medical assistance is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, using the number 1-800-222-1222.
Side Effects
Patients should be aware of the following warnings and precautions 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 persists or worsens, it is important to discontinue use and consult a healthcare professional. The product should not be used for longer than one week unless specifically directed by a doctor.
Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.
Drug Interactions
No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Maximum Strength Cold Sore Treatment (camphor, menthol, phenol, white petrolatum). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Gel |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.
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 are no specific warnings, precautions, or dosage modifications regarding the use of MAXIMUM STRENGTH COLD SORE TREATMENT in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or if there are any associated risks to the fetus. Additionally, no safety concerns related to the use of this product during pregnancy have been provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product 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 concerning 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 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 this drug. 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222 for guidance.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.
Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.
Nonclinical Toxicology
No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.
Postmarketing Experience
Serious side effects associated with the use of this product may be reported through the designated contact number. Reports received voluntarily or through surveillance programs contribute to the ongoing assessment of the product's safety profile.
Patient Counseling
Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a healthcare provider if their condition persists or worsens. Additionally, patients should be informed not to use the product for longer than one week unless specifically directed by a healthcare professional.
While using this product, patients must be cautioned to avoid contact with their eyes and to use the product only as directed. This guidance is essential to ensure safe and effective use of the product.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Maximum Strength Cold Sore Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.