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Methyl salicylate/Menthol, unspecified form

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 9 mg/100 mg
  • Methyl Salicylate 3 mg/100 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
February 23, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 9 mg/100 mg
  • Methyl Salicylate 3 mg/100 mg
Other brand names
Dosage form
Cream
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 2020
Label revision date
February 23, 2022
Manufacturer
Guangzhou Meayon Biotechnology Co,. Ltd
Registration number
part348
NDC root
75728-003
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 cream is designed to help relieve pain and reduce fever when applied to the skin. You can use it by gently rubbing the cream onto the affected area, which allows it to work directly where you need relief. The product is formulated to provide effective results, making it a supportive option for managing discomfort.

Uses

You can use this cream to help relieve pain by rubbing it directly onto the affected area. Additionally, it can be massaged onto the skin to help reduce fever. This product is designed to provide comfort and support for your symptoms.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this cream, making it a safer option for use.

Dosage and Administration

This medication is designed to help relieve various aches and pains, including those caused by arthritis, sprains, backaches, skin irritations, eczema, insect bites, sunburn, and reactions to poison ivy, poison oak, or poison sumac.

While the specific instructions on how often to use it or the method of application are not detailed, you can apply it as needed to the affected areas. Always ensure that you follow any additional guidance provided by your healthcare professional to achieve the best results.

What to Avoid

It's important to be cautious when using this medication. Do not use it if you feel uncomfortable at any point; please stop using it immediately. Additionally, keep the medication away from your eyes and make sure to wash your hands after use to avoid any irritation.

For safety, always keep this medication out of reach of children. If you have any concerns or experience discomfort, don't hesitate to stop using it and consult a healthcare professional. Your well-being is the priority.

Side Effects

This product is intended for external use only and should not be used by pregnant women, children under 8, or on injured skin. If you experience any discomfort while using it, please stop immediately. It's important to keep the product away from your eyes and wash your hands after application. Additionally, ensure that it is stored out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

This product is intended for external use only. It is not safe for pregnant women, children under 8 years old, or for use on injured skin. Always keep it out of reach of children, and be sure to wash your hands after using it. Avoid contact with your eyes, as this can cause irritation.

If you experience any discomfort while using this product, stop using it right away and contact your doctor for further advice. 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 the specific signs of an overdose are not detailed, common 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 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

This product is intended for external use only and is not safe for pregnant women or children under the age of 8. If you are pregnant or planning to become pregnant, it is important to avoid using this product entirely.

If you experience any discomfort while using it, please stop immediately. Your health and safety, as well as that of your child, should always come first.

Lactation Use

If you are breastfeeding, it's important to know that this product is intended for external use only. It is not recommended for pregnant women or children under the age of 8. If you experience any discomfort while using it, please stop immediately. Always prioritize your health and the well-being of your nursing infant when considering any products.

Pediatric Use

You should be aware that this product is not safe for children under 8 years old. If your child is younger than this age, it is important to avoid using this medication. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

When considering the use of HEMP CREAM for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult, it’s wise to consult with a healthcare professional before starting any new treatment, including HEMP CREAM, to ensure it is appropriate and safe for their individual health needs.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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, and there are no special monitoring or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health needs.

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 interactions with other drugs or laboratory tests. However, always ensure that your healthcare provider is aware of all the medications you are using, as they can help monitor your health and adjust treatments as necessary. This way, you can avoid any potential issues and ensure the best outcomes for your health.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at temperatures between 35°F and 80°F. This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Proper storage and careful handling are essential for ensuring the product works effectively and safely.

Additional Information

This medication is intended for external use only and should not be applied to pregnant women, children under 8 years old, or on injured skin. If you experience any discomfort while using it, stop immediately. Be sure to keep the product away from your eyes and wash your hands thoroughly after application. Additionally, always store it out of reach of children to ensure their safety.

FAQ

What is the method of using this cream?

You should rub the cream on the area of pain and massage it to relieve fever.

What conditions does this cream relieve?

It is effective for relieving aches and pains associated with arthritis, sprains, backaches, skin irritations, eczema, insect bites, sunburn, and poison ivy, oak, or sumac.

Are there any teratogenic effects associated with this cream?

No teratogenic effects have been mentioned for this cream.

What precautions should I take when using this cream?

Keep the cream away from your eyes, wash your hands after use, and keep it out of reach of children.

Who should not use this cream?

This cream is forbidden for pregnant women, children under 8 years old, and should not be applied to injured skin.

What should I do if I feel uncomfortable while using the cream?

You should stop using the cream immediately if you feel uncomfortable.

What is the storage temperature for this cream?

Store the cream between 35°F and 80°F.

Is this cream for internal use?

No, this cream is for external use only.

Packaging Info

Below are the non-prescription pack sizes of Hemp Cream. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hemp Cream.
Details

Drug Information (PDF)

This file contains official product information for Hemp Cream, 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 the SPL code 34089-3. It is available in a dosage form of 2000 mg, with the specific identifier 75728-003-01.

Uses and Indications

This drug is indicated for the topical relief of pain and the alleviation of fever through massage application. It is intended for use by healthcare professionals and patients seeking symptomatic relief from discomfort associated with pain and fever.

There are no teratogenic or nonteratogenic effects associated with this drug, indicating a favorable safety profile in these contexts.

Dosage and Administration

The product is indicated for the relief of aches and pains associated with conditions such as arthritis, sprains, backaches, skin irritations, eczema, insect bites, sunburn, and reactions to poison ivy, poison oak, and poison sumac.

Healthcare professionals should assess the individual needs of the patient when determining the appropriate dosage. Specific instructions regarding the route, method, and frequency of administration are not provided; therefore, it is recommended to follow standard practices for topical application.

Patients should be advised to apply the product to the affected area as needed, ensuring that the skin is clean and dry prior to application. Care should be taken to avoid contact with eyes and mucous membranes. If symptoms persist or worsen, patients should seek further medical advice.

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should not be used if the patient experiences discomfort during application. Immediate cessation of use is advised under such circumstances.

  • The product must be kept away from the eyes. In case of contact, rinse thoroughly with water.

  • It is essential to keep this product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

For external use only, this product is contraindicated in pregnant women and children under the age of 8, as well as on injured skin. Healthcare professionals should advise patients to discontinue use immediately if they experience any discomfort.

It is imperative to avoid contact with the eyes; users should wash their hands thoroughly after application to prevent accidental exposure. Additionally, this product must be kept out of reach of children to ensure safety.

In the event of discomfort, patients are instructed to stop using the product and consult their healthcare provider for further guidance.

Side Effects

Patients should be aware that the product is intended for external use only and is contraindicated for pregnant women, children under the age of 8, and on injured skin. It is crucial for patients to discontinue use immediately if they experience any discomfort.

Additionally, the product should be kept away from the eyes, and hands should be washed thoroughly after application to prevent any unintended exposure. It is also important to keep the product out of reach of children to ensure their safety.

These warnings highlight the necessity for careful handling and monitoring during use to mitigate potential adverse reactions.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there is no information regarding interactions between this drug and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hemp Cream. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hemp Cream.
Details

Pediatric Use

Pediatric patients under 8 years of age are contraindicated from using this product. There are no established safety or efficacy profiles for this age group, and the use of this product in children younger than 8 years is not recommended.

Geriatric Use

There is no specific information regarding the use of HEMP CREAM in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or unusual responses in this population is advisable, given the lack of established guidelines for geriatric use.

Pregnancy

Pregnant patients should be advised that this product is for external use only and is contraindicated in women who are pregnant. The use of this product is forbidden for pregnant women and children under 8 years of age. Healthcare professionals should counsel patients to discontinue use immediately if they experience any discomfort. Given the lack of specific studies on the effects of this product during pregnancy, caution is warranted, and the potential risks to fetal outcomes should be carefully considered.

Lactation

Lactating mothers should be aware that this product is intended for external use only. There is no available data on the excretion of this product in breast milk or its effects on breastfed infants. Due to the lack of safety information, it is advised that lactating mothers avoid using this product. Additionally, it is forbidden for pregnant women and children under 8 years of age. If any discomfort is experienced during use, lactating mothers should discontinue use immediately.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

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

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is contraindicated for use in pregnant individuals and children under the age of 8. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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 or misuse. It is important for patients to be informed that they should discontinue use immediately if they experience any discomfort or adverse reactions. Additionally, patients should be instructed to avoid contact with the eyes and to wash their hands thoroughly after application to ensure safety and minimize the risk of irritation.

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 within a temperature range of 35°F to 80°F to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients that it is contraindicated for pregnant women, children under 8 years of age, and on injured skin. Patients are instructed to discontinue use immediately if they experience any discomfort. Additionally, it is important to keep the product away from the eyes and to wash hands thoroughly after application. The product should be stored out of reach of children.

Drug Information (PDF)

This file contains official product information for Hemp Cream, 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 Hemp Cream, 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.