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Amrutanjan Relief Strong Pain Balm

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Active ingredients
  • Menthol, Unspecified Form 0.15 g/1 g
  • Methyl Salicylate 0.15 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 0.15 g/1 g
  • Methyl Salicylate 0.15 g/1 g
Other brand names
Dosage form
Ointment
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 2025
Label revision date
July 22, 2025
Manufacturer
AMRUTANJAN HEALTH CARE LIMITED
Registration number
M017
NDC root
53554-020
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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 is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. By targeting these specific areas of discomfort, it aims to help you feel more comfortable and improve your mobility.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for common issues such as simple backaches, arthritis, strains, bruises, and sprains.

You can rely on it to ease discomfort associated with these conditions, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage these minor ailments.

Dosage and Administration

If you are an adult or a child over 12 years old, you can apply the medication gently to the affected area 2 to 3 times a day. It's important to follow your doctor's instructions if they provide specific guidance. However, make sure not to apply it more than 3 times in a single day.

For children under 12 years of age, you should not use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to treating younger children.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

You should be aware that this product is for external use only and should not be applied to wounds, damaged skin, or mucous membranes. Avoid using it near an open flame, and follow the directions carefully. While using this product, take care to prevent contact with your eyes, and do not apply tight bandages or use heating pads. It’s important not to microwave or heat the product, as this can cause splattering and burns.

If your condition worsens, persists for more than seven days, or is accompanied by fever, rash, or persistent headaches, stop using the product and consult a doctor. Additionally, if you notice any redness or irritation, discontinue use. Keep this product out of reach of children, and if swallowed, seek medical help immediately. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Warnings and Precautions

This product is for external use only, so please avoid using it on wounds, damaged skin, or mucous membranes. Do not apply it near an open flame, and always follow the directions provided. While using this product, be careful not to get it in your eyes, and avoid tightly bandaging the area or using it with a heating pad. Never microwave or heat the product, and do not add it to hot water, as this can cause splattering and burns.

If your condition worsens, symptoms last more than 7 days, or if they clear up and return within a few days, especially if accompanied by fever, rash, or persistent headaches, stop using the product and consult your doctor. Additionally, if you notice any redness or irritation, discontinue use and seek medical advice. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

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 treatment for your child, it's important to know that it should not be used in children under 12 years of age without consulting a doctor. For those aged 12 and older, you can apply the product gently to the affected area 2 to 3 times a day, or as directed by a healthcare professional. However, make sure not to exceed three applications in a single day. Always prioritize your child's safety by following these guidelines closely.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney 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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. This helps maintain its effectiveness. Additionally, always check the packaging before purchasing; if the carton seal is broken or tampered with, do not buy it, as this could indicate that the product is unsafe to use.

By following these simple guidelines, you can help ensure that your product remains safe and effective for your needs.

Additional Information

You should apply this topical product gently to the affected area 2-3 times a day, unless your doctor advises otherwise. Make sure not to exceed three applications in a day. If you are under 12 years old, consult a doctor before using this product.

Before using, it's important to test a small area of your skin first, as some individuals may experience an allergic reaction. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

How should adults and children over 12 years use this drug?

Adults and children over 12 years should apply it gently to the affected area 2-3 times daily, or as directed by a doctor, without exceeding 3 times daily.

Can children under 12 years use this drug?

No, children under 12 years of age should not use this drug without consulting a doctor.

What precautions should I take when using this drug?

This drug is for external use only. Avoid using it on wounds or damaged skin, near an open flame, and do not bandage tightly or use with a heating pad.

What should I do if I accidentally swallow this drug?

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

What should I do if my condition worsens or symptoms persist?

Stop using the drug and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience redness or irritation.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this drug.

How should I store this drug?

Store the drug at room temperature and do not purchase if the carton seal is broken or tampered.

Packaging Info

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

Packaging configurations for Amrutanjan Relief Strong Pain Balm.
Details

Drug Information (PDF)

This file contains official product information for Amrutanjan Relief Strong Pain Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is a strong balm formulated for relief. It is designed to provide targeted comfort and support for various discomforts. The balm's composition and application method are intended to enhance its efficacy in delivering relief.

Uses and Indications

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

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

Dosage and Administration

Adults and children over 12 years of age should apply the medication gently to the affected area 2 to 3 times daily, or as directed by a healthcare professional. It is important not to exceed the maximum application frequency of 3 times daily.

For children under 12 years of age, the use of this medication is not recommended without prior consultation with a healthcare provider.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product should not be applied to wounds, damaged skin, mucous membranes, or broken or irritated skin. It is imperative to avoid using the product near an open flame and to adhere strictly to the directions provided.

When utilizing this product, it is essential to avoid contact with the eyes. Users should refrain from tightly bandaging the area or using it in conjunction with a heating pad. Additionally, the product must not be microwaved, heated, or added to hot water or any container where water is being heated, as this may lead to splattering and potential burns.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, or are accompanied by fever, rash, or persistent headaches, the user should discontinue use and consult a healthcare professional. Furthermore, if any redness or irritation develops, it is advised to stop use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to using this product.

General precautions include keeping the product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is for external use only and must not be applied to wounds, damaged skin, mucous membranes, or broken or irritated skin. It is also contraindicated for use near an open flame and should only be used as directed.

During the use of this product, patients are advised to avoid contact with the eyes and to refrain from tightly bandaging the area or using it in conjunction with a heating pad. Additionally, the product should not be microwaved, heated, or added to hot water or any container where water is heating, as this may cause splattering and result in burns.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if the use of the product is accompanied by fever, rash, or persistent headaches. Development of redness or irritation at the application site also warrants cessation of use and medical consultation.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use.

It is crucial to keep this product 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 without delay.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Amrutanjan Relief Strong Pain Balm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents and children aged 12 years and older, the recommended application is to gently apply the medication to the affected area 2-3 times daily, or as directed by a healthcare professional. It is important to note that the medication should not be applied more than 3 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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

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

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 in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, it is essential to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of the overdosage.

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

Postmarketing experience has indicated that this product may cause allergic reactions in a small number of individuals. It is recommended that users conduct a patch test on a small area of skin prior to full application to assess for any potential sensitivity.

Additionally, serious side effects can be reported through the designated contact number, +1-866-799-6929, available Monday through Friday from 8:00 A.M. to 6:00 P.M.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in packaging that is tamper evident. Healthcare professionals are advised not to purchase the product if the carton seal is broken or tampered with.

For optimal storage, the product should be kept at room temperature. It is essential to ensure that the storage environment maintains this temperature range to preserve the integrity of the product.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children over 12 years being 2-3 times daily, or as directed by a healthcare professional, without exceeding three applications per day. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product may cause an allergic reaction in some individuals; therefore, a patch test on a small area of skin is recommended before full application. Additionally, patients who are pregnant or breastfeeding should seek advice from a healthcare professional before using the product.

Drug Information (PDF)

This file contains official product information for Amrutanjan Relief Strong Pain Balm, 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 Amrutanjan Relief Strong Pain Balm, 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.