Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Keratek

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Menthol 16 g/100 g
  • Methyl Salicylate 28 g/100 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 2013
Label revision date
October 21, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 16 g/100 g
  • Methyl Salicylate 28 g/100 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 2013
Label revision date
October 21, 2013
Manufacturer
GERITREX CORP
Registration number
part348
NDC root
54162-540
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

You may be looking for a medication that is used to treat certain conditions affecting the skin. While the specific name and details of the drug are not provided, it is important to know that this medication is typically applied to the affected area. It is generally recommended for use in adults and children aged 12 years and older, with a limit of 3 to 4 applications per day. If you have a child under 12, it's best to consult a doctor before use. Always remember to use the medication only as directed for the best results.

Uses

You can use this medication to treat specific skin conditions by applying it to the affected area. For adults and children aged 12 years and older, it's recommended to apply the medication no more than 3 to 4 times a day. If you have a child under 12, it's best to consult a doctor before use.

This medication has been evaluated and does not show any teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects that could occur). Always follow your healthcare provider's advice for the best results.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. If you have any questions about how to use the medication or if you notice any unusual reactions, be sure to consult with your healthcare provider.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help or contact a Poison Control Center right away. There are no specific contraindications, risks of abuse or misuse, or dependence concerns mentioned, but always use medications responsibly and as directed.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return within a few days. Additionally, if you experience excessive skin irritation, seek medical advice.

This product is for external use only and should not be applied to wounds, damaged skin, or used with a heating pad. It is also not recommended for children under 12 years of age with arthritis-like conditions. Be cautious to avoid contact with your eyes or mucous membranes, and do not bandage the area tightly. If you notice any redness over the affected area, consult your doctor before continuing use.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, damaged skin, or using it with a heating pad. It is not recommended for children under 12 years old who have arthritis-like conditions. If you notice any redness in the area you plan to treat, consult your doctor before using the product. While using it, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly.

You should stop using the product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation. If the product is swallowed, seek medical help or contact a Poison Control Center right away.

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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

It’s important to note that there is no specific information available about the use of KERATEK (menthol, methyl salicylate gel) during pregnancy. This means that if you are pregnant or planning to become pregnant, you should be cautious and consult your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for your situation. Always prioritize your health and the health of your baby when considering any medication.

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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old, you should consult a doctor before use. Additionally, do not use this medication on children under 12 who have arthritis-like conditions.

Always keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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 provide guidance based on your individual situation.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times a day. It's important to keep this product out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help or contact a Poison Control Center right away.

FAQ

How should I use this medication?

You should apply it to the affected area not more than 3 to 4 times daily.

Can children use this medication?

Children under 12 years of age should ask a doctor before use.

What should I do if I accidentally swallow this medication?

Keep it out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, and avoid contact with eyes or mucous membranes.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is there any information regarding use during pregnancy or breastfeeding?

There is no specific information provided regarding use during pregnancy or breastfeeding.

What is the storage requirement for this medication?

Store the medication at 20°C to 25°C (68°F to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Keratek (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Keratek.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3 in the provided text.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. It should be applied no more than 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. It is essential to ensure that the area is clean and dry prior to application. Healthcare professionals should instruct patients to use the product as directed and to avoid applying it to broken or irritated skin.

Contraindications

Use is contraindicated in situations where accidental ingestion by children may occur. To mitigate the risk of harm, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on wounds, damaged skin, or in conjunction with a heating pad. Additionally, it should not be used on children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes and mucous membranes, and to refrain from tightly bandaging the treated area.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to recur within a few days; or if excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that the product is for external use only and should not be applied to wounds or damaged skin. It is contraindicated for use with a heating pad and is not recommended for children under 12 years of age who have arthritis-like conditions. Prior to use, patients are advised to consult a healthcare professional if there is redness over the affected area.

During the application of this product, it is important to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the area.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation develops.

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 Keratek (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Keratek.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor before use. The medication should not be applied to children under 12 years of age who have arthritis-like conditions.

Additionally, it is important to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 information available regarding the use of KERATEK (menthol, methyl salicylate gel) during pregnancy. As such, the potential risks to pregnant patients and fetal outcomes remain undetermined. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the benefits against any unknown risks. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with ingestion by children.

In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This prompt action is crucial to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients are instructed to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Keratek, 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 Keratek, 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.