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El Balsamo De Tigre

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Active ingredients
  • Menthol, Unspecified Form 3.5 g/100 g
  • Methyl Salicylate 10 g/100 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 2024
Label revision date
January 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 3.5 g/100 g
  • Methyl Salicylate 10 g/100 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 2024
Label revision date
January 13, 2025
Manufacturer
Miramar Cosmetics, Inc DBA Miramar Lab
Registration number
M017
NDC root
79974-208
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

Miramar-208 is a medication designed to help relieve minor aches and pains associated with muscles, joints, strains, backaches, sprains, and sports injuries. If you're experiencing discomfort from these common issues, Miramar-208 may provide the relief you need to feel more comfortable and active.

Uses

You can use this medication to help relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including strains, backaches, sprains, and sports injuries. Whether you're dealing with discomfort from everyday activities or a recent injury, this medication can provide the relief you need to get back to your routine.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than three times a day. It's normal to feel a temporary burning sensation when you first apply it, but this should go away with continued use. After applying the medication, make sure to wash your hands thoroughly. If you applied it to your hands, wait at least 30 minutes before washing them to ensure the medication has time to work.

If you are an adult or a child aged 12 years or older, you can expect to feel initial pain relief within 1 to 2 weeks of starting the treatment. However, if you are considering using this medication for a child under 12 years old, it's important to consult a physician (doctor) first to ensure it's safe and appropriate for them.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence, you should avoid bandaging the area where the medication is applied. This precaution helps ensure the medication works effectively and safely. Always follow your healthcare provider's instructions for the best results.

Side Effects

When using this product, it's important to remember that it is for external use only. You should not use it if you are allergic to salicylates (a group of medications that includes aspirin) without first consulting your doctor. Additionally, avoid applying it to open wounds, damaged skin, or immediately before or after showering.

If you notice that your condition worsens, symptoms persist, or if you experience skin irritation, stop using the product and consult your doctor. Be careful to keep the product away from your eyes, lips, and any mucous membranes to prevent irritation.

Warnings and Precautions

This product is for external use only. You should not use it if you are allergic to salicylates (like aspirin) unless you have consulted with your doctor. Avoid applying it on open wounds, damaged or irritated skin, and do not use it immediately before or after taking a shower. While using this product, be careful to keep it away from your eyes, lips, and any mucous membranes.

If you notice that your condition worsens, symptoms persist, or if you experience skin irritations, stop using the product and contact your doctor. Always keep this product out of reach of children. If swallowed, seek medical help immediately. Remember, do not bandage the area where you apply this product.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help right away. Overdosing can lead to serious health issues, so don’t wait to get assistance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you suspect an overdose, contacting a healthcare professional immediately is crucial. Always prioritize safety and don’t hesitate to reach out for help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain medications. You should avoid using this product if you are allergic to salicylates, which include aspirin, unless you have consulted with your doctor. Additionally, this product is intended for external use only, so be sure to follow that guideline carefully.

If you have children under 12 years old, it's advisable to consult a physician before using this product on them. Always prioritize safety and seek professional advice when it comes to medication during pregnancy.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby by seeking professional advice.

Pediatric Use

If you have a child under 12 years old, it's important to consult a physician (a medical doctor) before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but make sure not to exceed three applications in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

While there is no specific information about the use of El Bálsamo de Tigre in older adults, it's important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can help ensure that it is appropriate for your needs and consider any other medications or health conditions you may have. Always prioritize your safety and well-being when trying new treatments.

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 there are no special monitoring requirements or safety considerations outlined for patients like you with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can provide guidance tailored to your health needs.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of potential interactions with any medications you take. If you are allergic to salicylates, which include aspirin, you should consult your healthcare provider before using this medication. This is crucial to ensure your safety and avoid any adverse reactions.

While there are no specific laboratory test interactions noted, it's always a good practice to discuss all your medications and any upcoming tests with your healthcare provider. They can help you understand how your treatments may affect each other and ensure you receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 15-25°C (59-77°F). Keeping it within this range helps maintain its effectiveness and integrity.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

You should apply this medication topically to the affected area, no more than three times a day if you are an adult or a child aged 12 years or older. While using the product, be careful to avoid contact with your eyes, lips, and any mucous membranes.

If your condition worsens, symptoms persist, or you experience skin irritation, stop using the product and consult a doctor. Keep the medication out of reach of children, and if swallowed, seek medical help immediately. Do not bandage the area after application.

FAQ

What is Miramar-208 used for?

Miramar-208 helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

How should I apply Miramar-208?

You should apply Miramar-208 to the affected area no more than 3 times daily.

What should I do if I experience burning after applying Miramar-208?

Temporary burning may occur when applied, but it should disappear with continued use.

Is Miramar-208 safe for children under 12?

You should consult a physician before using Miramar-208 on children under 12 years of age.

Are there any contraindications for using Miramar-208?

Do not use Miramar-208 if you are allergic to salicylates (including aspirin) without consulting a physician.

What precautions should I take when using Miramar-208?

Avoid contact with eyes, lips, and any mucous membranes, and do not bandage the area after application.

What should I do if my symptoms worsen or persist?

Stop using Miramar-208 and ask a doctor if your conditions worsen, symptoms persist, or skin irritation occurs.

How should I store Miramar-208?

Store Miramar-208 at a temperature between 15-25° C (59-77° F).

What should I do if Miramar-208 is swallowed?

If swallowed, seek medical help immediately.

Packaging Info

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

Packaging configurations for El Balsamo De Tigre.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Miramar-208 is identified by the SPL code 34089-3. This compound is characterized by its specific chemical properties and formulation, which are essential for its intended use in medical applications. Further details regarding its molecular weight, chemical formula, and dosage form are critical for understanding its pharmacological profile and therapeutic potential.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with muscles, joints, strains, backaches, sprains, and sports injuries.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area no more than three times daily. Patients may experience a temporary burning sensation upon application; however, this discomfort typically resolves with continued use. It is advised to wash hands thoroughly after application. If the liniment is applied to the hands, patients should wait at least 30 minutes before washing their hands to ensure optimal absorption.

Initial pain relief is generally observed within 1 to 2 weeks of consistent use.

For children under 12 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in situations where bandaging is required, as it may compromise the intended therapeutic effect or lead to adverse outcomes. No other contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients not to use this product if they have a known allergy to salicylates, including aspirin, without prior consultation with a physician. Additionally, the product should not be applied to open wounds, damaged or irritated skin, or immediately before or after showering.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist, or if any skin irritations occur. While using this product, it is crucial to avoid contact with the eyes, lips, and any mucous membranes to prevent adverse reactions.

Healthcare providers must emphasize the importance of keeping this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought. Furthermore, patients should be cautioned against bandaging the area where the product is applied, as this may lead to increased absorption and potential side effects.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated in individuals who are allergic to salicylates, including aspirin, unless they have consulted a physician. The product should not be applied to open wounds, damaged or irritated skin, or immediately before or after taking a shower.

During the use of this product, patients are advised to avoid contact with the eyes, lips, and any mucous membranes. If any adverse reactions occur, such as worsening of conditions, persistent symptoms, or skin irritation, patients should discontinue use and consult a doctor.

Drug Interactions

Patients with a known allergy to salicylates, including aspirin, should avoid the use of this medication unless they have consulted with a physician. This precaution is essential to prevent potential allergic reactions.

There are no specific laboratory test interactions associated with this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

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

Packaging configurations for El Balsamo De Tigre.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than three times daily.

Geriatric Use

There is no specific information regarding the use of El Bálsamo de Tigre in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of potential risks and benefits.

Pregnancy

Pregnant patients should be advised against the use of this product if they have a known allergy to salicylates, including aspirin, without prior consultation with a physician. The safety of this product during pregnancy has not been established, and it is recommended that pregnant patients exercise caution.

This product is intended for external use only, and its effects on fetal outcomes have not been thoroughly studied. Therefore, healthcare professionals should consider the potential risks and benefits before recommending this product to women of childbearing potential. Additionally, it is advised that children under 12 years consult a physician before use, which may also apply to pregnant patients in this age group.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific guidelines are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is essential. Healthcare professionals should advise patients or caregivers to seek medical help promptly if the substance is ingested.

Potential symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is crucial.

Management of overdosage should be guided by the clinical presentation and may include supportive care and symptomatic treatment as necessary. It is imperative to monitor the patient closely and provide appropriate interventions based on the severity of symptoms observed.

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 available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should seek medical assistance immediately. Additionally, it is important to inform patients that they should not bandage the area where the medication is applied, as this may interfere with its effectiveness or cause adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-25° C (59-77° F) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's integrity.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than three times daily for adults and children aged 12 years or older. Clinicians should advise patients to stop use and consult a doctor if conditions worsen, symptoms persist, or skin irritation occurs. While using the product, patients should avoid contact with the eyes, lips, and any mucous membranes. It is also important to keep the product out of reach of children; if swallowed, medical assistance should be sought, and bandaging should be avoided.

Drug Information (PDF)

This file contains official product information for El Balsamo De Tigre, 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 El Balsamo De Tigre, 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.