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Liberdol Topical Analgesic

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Active ingredients
  • Camphor (synthetic) 40 mg/1 mL
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 300 mg/1 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 1, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 40 mg/1 mL
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 300 mg/1 mL
Other brand names
Dosage form
Spray
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 2021
Label revision date
December 1, 2023
Manufacturer
ViaDerma Distribution, Inc
Registration number
M017
NDC root
71262-008
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 provides soothing, on-the-go temporary relief from minor aches and pains associated with sore muscles and joints. It is particularly helpful for conditions such as arthritis, backache, strains, and sprains. If you're experiencing discomfort from these issues, this drug may offer you the relief you need to feel more comfortable throughout your day.

Uses

You can use this product for soothing, on-the-go temporary relief from minor aches and pains in your muscles and joints. It is particularly helpful for discomfort associated with conditions like arthritis, backaches, strains, and sprains.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects noted, making it a safe option for managing your pain.

Dosage and Administration

You can apply this medication to the affected areas of your skin up to four times a day. This is suitable for both adults and children who are 2 years old and older. If you have a child who is under 2 years of age, it’s important to consult a physician (doctor) before using this medication to ensure it’s safe for them. Always follow these guidelines to help manage your condition effectively.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to open wounds or damaged skin, and avoid using it alongside other ointments, creams, sprays, or liniments. If your skin is irritated or if you experience excessive irritation, discontinue use immediately. Additionally, do not bandage the area after application, and refrain from using it with heating pads or devices, as this can lead to unwanted effects.

By following these guidelines, you can help ensure a safe and effective experience with the product.

Side Effects

When using this product, it's important to be aware of certain precautions. This product is for external use only and is flammable, so keep it away from excessive heat or open flames. If you have sensitive skin, are pregnant, or are bleeding, consult your doctor before use. Avoid contact with your eyes and mucous membranes, and do not apply it to open wounds, damaged skin, or irritated areas. It's also advised not to use it with other ointments or heating devices.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then reoccur, stop using the product and consult your doctor. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only and should be kept away from heat or open flames, as it is flammable. Before using it, consult your doctor if you have sensitive skin, are pregnant, or are experiencing bleeding. While using the product, avoid contact with your eyes and mucous membranes, and do not apply it to open wounds or damaged skin. It's important not to use it alongside other ointments, creams, sprays, or heating devices, and avoid bandaging the area.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then reoccur, stop using the product and contact your doctor. Always keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make safe choices for your health and your baby's well-being. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can use Liberdol Topical Analgesic Spray without specific warnings or recommendations against it. Currently, there is no information available about whether this spray is passed into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products 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 should consult a physician (doctor) before applying the medication. You can apply it to the affected areas up to four times a day, but always ensure you have professional guidance first.

For children under 2 years of age, there are no specific instructions provided, so it's best to avoid using the medication unless directed by a healthcare professional. Always prioritize your child's safety and well-being by seeking advice from a doctor when it comes to their health.

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 before starting the medication. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 help determine the best course of action based on your kidney function and overall health.

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to be cautious when using this medication. You should avoid applying it alongside other ointments, creams, sprays, or liniments, as this can lead to unwanted effects. Additionally, do not use it with a heating pad or any heating device, as this may increase the risk of irritation or other complications.

Always discuss any medications or treatments you are considering with your healthcare provider. They can help ensure that you use this medication safely and effectively, taking into account any other products you may be using.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place, away from direct sunlight. This helps maintain its effectiveness and prevents any potential damage.

When handling the product, always ensure that your hands are clean and dry to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this product to the affected areas no more than four times a day. Remember, it is for external use only, so keep it away from excessive heat or open flames, as it is flammable. Before using, consult a doctor if you have sensitive skin, are pregnant, or are bleeding.

While using this product, avoid contact with your eyes or mucous membranes, and do not apply it to open wounds or damaged skin. It's important not to use it with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin. Do not bandage the area or use it with heating pads or devices. If your condition worsens, symptoms persist for more than seven days, or if they clear up and then reoccur, stop using the product and consult a doctor. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug provides soothing on-the-go temporary relief from minor aches and pains of sore muscles and joints associated with conditions like arthritis, backache, strains, and sprains.

How often can I apply this drug?

You can apply it to affected areas not more than 4 times daily.

Are there any precautions for children?

Consult a physician for children under 2 years of age before use.

What should I avoid while using this product?

Avoid contact with eyes or mucous membranes, and do not apply to open wounds, damaged skin, or irritated skin. Do not use with other ointments, creams, sprays, or heating devices.

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 this drug safe to use during pregnancy?

Ask a doctor before use if you are pregnant.

What should I do if the product is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Is there any information regarding nursing mothers?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers.

What are the storage instructions for this drug?

Store in a cool, dry place out of direct sunlight.

What are the flammability warnings?

This product is for external use only and is flammable, so keep it away from excessive heat or open flame.

Packaging Info

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

Packaging configurations for Liberdol Topical Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is presented in a dual packaging format, consisting of an outer package and an inner package, both of which are depicted in accompanying images. The outer package is designed to provide protection and information regarding the product, while the inner package contains the actual dosage form. The effective date of this labeling is June 8, 2021.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug, making it suitable for use without concerns regarding these specific risks.

Dosage and Administration

The medication should be applied to the affected areas no more than four times daily. For adults and children aged 2 years and older, the recommended application frequency is up to four times per day.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Application to open wounds or damaged skin is prohibited due to the risk of exacerbating injury or infection. The use of this product in conjunction with other ointments, creams, sprays, or liniments is contraindicated to prevent potential interactions that may alter efficacy or safety. Application to irritated skin or in cases where excessive irritation develops is not advised, as this may worsen the condition. Bandaging over the application site is contraindicated to ensure proper ventilation and avoid trapping moisture. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the potential for increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; it should be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin, are pregnant, or are experiencing bleeding.

During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to open wounds or damaged skin. Additionally, it is contraindicated to use this product in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, nor should the product be used with heating pads or devices.

Patients must be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

This product should be stored out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Patients are advised to consult a doctor prior to use if they have sensitive skin, are pregnant, or are experiencing bleeding.

During the use of this product, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to open wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin, and if excessive irritation develops, they should discontinue use. Bandaging the area after application is not recommended, and the product should not be used with heating pads or devices.

Patients are instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance absorption and increase the potential for systemic effects, which could lead to unintended complications.

It is advised to monitor for any signs of irritation or adverse reactions when using this medication, particularly in the absence of other topical agents or heat sources.

Packaging & NDC

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

Packaging configurations for Liberdol Topical Analgesic.
Details

Pediatric Use

Pediatric patients may apply the medication to affected areas no more than four times daily. For children aged 2 years and older, it is recommended to consult a physician prior to use. There are no specific instructions provided for children under 2 years of age.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate risk assessment and management.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

When using this product, patients should be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to open wounds or damaged skin, and it is essential to refrain from using it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be informed not to apply the product to irritated skin or if excessive irritation develops. Additionally, they should not bandage the area after application or use it with a heating pad or device.

Healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin, are pregnant, or are experiencing bleeding.

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 in a cool, dry place, ensuring it is protected from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should apply the product to affected areas no more than four times daily. It is for external use only and must be kept away from excessive heat or open flame, as it is flammable. Clinicians should advise patients to consult a doctor before use if they have sensitive skin, are pregnant, or are bleeding.

While using the product, patients should avoid contact with eyes and mucous membranes, and it should not be applied to open wounds, damaged skin, or irritated areas. Patients should refrain from using it in conjunction with other ointments, creams, sprays, or liniments, and should not bandage the area or use it with heating pads or devices. If the condition worsens, symptoms persist for more than seven days, or if symptoms clear up and reoccur, patients should stop use and consult a doctor. The product should be kept out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Liberdol Topical Analgesic, 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 Liberdol Topical Analgesic, 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.

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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.