Symptom checker
Select audience type

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

ADD CONDITION

items per page

Duane Reade

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Menthol 5.62 mL/74 mL
  • Methyl Salicylate 21.46 mL/74 mL
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 2011
Label revision date
February 25, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 5.62 mL/74 mL
  • Methyl Salicylate 21.46 mL/74 mL
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 2011
Label revision date
February 25, 2011
Manufacturer
Duane Reade
Registration number
part348
NDC root
24488-023
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 information about a medication that is used for specific conditions. This drug is designed to help treat certain health issues, although the exact conditions it addresses are not specified in the provided information. It is important to use this medication only as directed by a healthcare professional to ensure safety and effectiveness.

While the details about how this drug works are not included, it is crucial to follow all instructions carefully, including avoiding contact with sensitive areas like your eyes or mucous membranes. If you have any questions about its use or effects, be sure to consult with your healthcare provider for more personalized guidance.

Uses

You should use this medication only as directed by your healthcare provider. It's important to avoid contact with your eyes or any mucous membranes, as this can lead to irritation. Additionally, you should not bandage the area tightly or use a heating pad while using this medication. It’s also crucial to refrain from applying it to wounds or damaged skin to ensure safety and effectiveness.

There are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, and there are no reported nonteratogenic effects either. Always follow your healthcare provider's instructions for the best results.

Dosage and Administration

To use this medication effectively, start by applying a generous amount to the area that is causing you pain. Make sure to massage it into your skin until it is fully absorbed. You can repeat this process as needed, but be careful not to apply it more than four times in a single day.

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to be aware of when to stop using this product. If your condition worsens, if you notice any redness, or if irritation develops, you should stop using it and consult a doctor. Additionally, if your symptoms persist for more than 7 days or if they clear up and then return within a few days, it's crucial to seek medical advice.

There are no specific contraindications or concerns regarding controlled substances, abuse, or dependence associated with this product. However, always prioritize your health and safety by following these guidelines.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to consult your doctor before using this product. This medication is intended for external use only.

You should stop using it and contact your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms persist for more than 7 days. Additionally, if your symptoms improve and then return within a few days, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return shortly after improving. It's important to pay attention to these signs to ensure your safety and well-being.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their needs.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it's always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

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 health situation. They can provide guidance based on your individual needs and kidney function.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). Your doctor can help determine if this medication is safe for you.

While there are no specific interactions with other drugs or laboratory tests noted, discussing all your current medications and any upcoming tests with your healthcare provider ensures your safety and the effectiveness of your treatment. Always keep your doctor informed about your health history and any concerns you may have.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until it is fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in a day. If the user is a child under 12, consult a doctor before use.

Before using this product, it's important to check with a doctor if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). Additionally, if you are pregnant or breastfeeding, you should speak with a healthcare professional for advice before using this medication.

FAQ

How should I use this drug?

Use only as directed. Apply generously to the affected area and massage until thoroughly absorbed into the skin.

What precautions should I take when using this drug?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and do not apply to wounds or damaged skin.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, if redness is present, or if irritation develops.

Is this drug safe for children?

For children under 12 years, consult a doctor before use.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Are there any known drug interactions?

If you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

Packaging Info

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

Packaging configurations for Duane Reade.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Placeholder Text is a topical formulation designed for application to the skin. The product is presented in a roll-on dosage form, facilitating ease of use. It is packaged in a container that is suitable for the delivery of the formulation. The appearance of the product is consistent with typical roll-on applications, and it is intended for use in providing localized relief. The media type associated with the product is image/jpeg, and the reference image is labeled as DR_Hot-n-Cold_Rollon.jpg.

Uses and Indications

This drug is indicated for use as directed. It is essential to avoid contact with the eyes or mucous membranes during application. The drug should not be bandaged tightly or used in conjunction with a heating pad. Additionally, it is contraindicated for application on wounds or damaged skin.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves applying a generous amount of the product to the affected area. The application should be followed by a gentle massage into the painful area until the formulation is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. These actions are crucial to ensure patient safety and to address any potential adverse reactions effectively.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this product. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use to mitigate the risk of an allergic reaction.

This product is intended for external use only. Patients should discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These warnings are crucial for ensuring patient safety and effective management of their condition.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to using this medication, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Duane Reade.
Details

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. It is important for patients to be aware of these signs to ensure their safety and the effective use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to consult a healthcare professional if they have a history of allergic reactions to aspirin or salicylates before using the product. Additionally, pregnant or breastfeeding patients are encouraged to seek medical advice prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Duane Reade, 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 Duane Reade, 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.