Symptom checker
Select audience type

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

ADD CONDITION

items per page

Ultra Balm

Last content change checked dailysee data sync status

Active ingredients
  • Menthol, Unspecified Form 140 mg/1 g
  • Methyl Salicylate 232 mg/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 2013
Label revision date
July 19, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 140 mg/1 g
  • Methyl Salicylate 232 mg/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 2013
Label revision date
July 19, 2024
Manufacturer
Ling Nam Medicine Factory (H. K.) Ltd.
Registration number
M017
NDC root
57598-888
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

ULTRA BALM is an external analgesic designed to provide temporary relief from minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. By applying ULTRA BALM to the affected area, you may experience soothing relief that can help you manage discomfort and maintain your daily activities.

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 various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on it to ease discomfort associated with these common issues, allowing you to get back to your daily activities with less pain. Remember, while it can help with these specific conditions, it's always a good idea to consult with a healthcare professional if you have any concerns.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children aged 12 years and older, you should apply it no more than 3 to 4 times a day. If you have a child who is 12 years old or younger, it's important to consult a doctor before using this medication.

Please note that this medication is not intended for children under the age of two. Always follow the recommended guidelines to ensure safe and effective use.

What to Avoid

If you are allergic to aspirin or salicylates, you should not use this product. It's important to follow the directions provided and avoid using it in any way that is not specified.

While using this product, make sure to keep it away from your eyes and mucous membranes. Do not apply it to any wounds, damaged, or irritated skin. Additionally, avoid tightly bandaging the area or using a heating pad with it. Lastly, refrain from using the product within one hour before bathing or within 30 minutes after bathing to ensure safety and effectiveness.

Side Effects

When using this product, it's important to be aware of certain precautions. This product is for external use only, so avoid contact with your eyes or mucous membranes. Do not apply it to wounds, damaged, or irritated skin, and refrain from tightly bandaging the area or using it with a heating pad. Additionally, avoid using it one hour before bathing or within 30 minutes after bathing.

You should stop using the product and consult a doctor if your condition worsens, if you experience skin irritation or redness, if pain lasts more than seven days, or if symptoms clear up and then return within a few days. If you are pregnant or breastfeeding, it's advisable to consult a healthcare professional before using this product. Also, do not use it if you have a known allergy to aspirin or salicylates.

Warnings and Precautions

This product is for external use only, so please avoid using it on broken or irritated skin, and do not apply it to wounds. If you have a known allergy to aspirin or salicylates, do not use this product. While using it, be careful to keep it away from your eyes and mucous membranes, and avoid tight bandaging or using it with a heating pad. Additionally, refrain from using it one hour before or thirty minutes after bathing.

If your condition worsens, you notice skin irritation or redness, or if your pain lasts more than seven days, stop using the product and consult your doctor. If your symptoms improve and then return within a few days, it's also important to reach out to your healthcare provider.

Keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek emergency medical help or contact the Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children to prevent accidental poisoning. If a child swallows it, you should seek medical help immediately or contact the Poison Control Center for guidance.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your 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 using this medication for your child, it's important to consult a doctor first if your child is 12 years old or younger. This is especially crucial for children under two years of age, as the medication is not intended for them.

For children aged 12 and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow your healthcare provider's guidance to ensure the safety and well-being of your child.

Geriatric Use

When considering the use of Ultra Balm for older adults, it's important to note that the drug insert does not provide specific information about how it should be used by this age group. This means there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional before starting any new medication, including Ultra Balm, to ensure it is appropriate for their individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 aware of potential interactions when taking medications. If you have a history of allergic reactions to aspirin or similar medications (known as salicylates), you should avoid using this drug. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always a good practice to inform your healthcare provider about all the medications and supplements you are taking. This helps ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance and safety of your product, always store it in a cool place. This helps maintain its effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the contents. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the user is a child under 12, it's important to consult a doctor before use. This medication is not intended for children under two years of age.

If you are pregnant or breastfeeding, be sure to ask your healthcare professional before using this product. Keep it out of reach of children to prevent accidental poisoning. If the medication is swallowed, seek medical help or contact the Poison Control Center immediately.

FAQ

What is ULTRA BALM used for?

ULTRA BALM is an external analgesic used for temporary relief of minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

How should I use ULTRA BALM?

For adults and children 12 years and older, apply ULTRA BALM to the affected area not more than 3 to 4 times daily. For children under 12, consult a doctor before use.

Are there any contraindications for using ULTRA BALM?

Do not use ULTRA BALM if you are prone to allergic reactions from aspirin or salicylates.

What should I avoid while using ULTRA BALM?

Avoid contact with eyes or mucous membranes, do not apply to wounds or irritated skin, and do not use with a heating pad or bandage tightly.

What should I do if my condition worsens while using ULTRA BALM?

Stop use and ask a doctor if your condition worsens, if skin irritation or redness develops, or if pain persists for more than 7 days.

Is ULTRA BALM safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ULTRA BALM.

What should I do if ULTRA BALM is swallowed?

Keep ULTRA BALM out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Ultra Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ULTRA BALM is an external analgesic product manufactured by Ling Nam Medicine Factory (H.K.) Limited, located in Tuen Mun, New Territories, Hong Kong, China. It is designed for pain relief and features a cooling effect. The product is distributed in the United States by TCM Herbalway Inc., based in Covina, CA 91724. ULTRA BALM is packaged in a net weight of 0.7 oz (19.8 g). The National Drug Code (NDC) for this product is 57598-888-07.

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

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use. This product is not intended for use in children under two years of age.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or salicylates due to the risk of severe allergic reactions.

The product should not be used in any manner other than as directed.

Contact with eyes or mucous membranes must be avoided. Application to wounds, damaged, or irritated skin is contraindicated. Additionally, the product should not be tightly bandaged or used in conjunction with a heating pad. It is also contraindicated to use the product within one hour prior to bathing or within 30 minutes after bathing.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a known hypersensitivity to aspirin or salicylates.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Application should not occur on wounds, damaged, or irritated skin. Additionally, it is advised not to bandage the area tightly or use in conjunction with a heating pad. Users should refrain from applying the product within one hour prior to bathing or within thirty minutes after bathing to ensure safety and efficacy.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of skin irritation or redness, persistence of pain beyond seven days, or if symptoms resolve only to recur within a few days.

Emergency medical assistance should be sought immediately if the product is ingested. It is crucial to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, contacting a Poison Control Center or seeking medical help is essential.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated in individuals who are prone to allergic reactions from aspirin or salicylates.

When using this product, patients are advised to avoid contact with the eyes or mucous membranes and to refrain from applying it to wounds, damaged, or irritated skin. Additionally, it is important not to bandage the area tightly or use the product in conjunction with a heating pad. Patients should also avoid using the product one hour prior to bathing or within 30 minutes after bathing.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, if skin irritation or redness develops, if pain persists for more than seven days, or if symptoms clear up and then recur within a few days.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a healthcare professional before using this product.

Drug Interactions

The use of this medication is contraindicated in individuals with a known hypersensitivity to aspirin or salicylates, as this may lead to severe allergic reactions.

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

Packaging & NDC

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

Packaging configurations for Ultra Balm.
Details

Pediatric Use

Pediatric patients 12 years of age and younger should consult a healthcare professional before use. This product is not intended for children under two years of age. For patients aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of Ultra Balm in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or changes in response to treatment is advisable in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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, it is crucial to take immediate action to ensure patient safety. The product should be kept out of reach of children to prevent accidental poisoning.

If ingestion occurs, it is imperative to seek medical assistance promptly. Healthcare professionals should advise contacting the Poison Control Center without delay for further guidance on management and treatment options.

Timely intervention is essential in mitigating potential adverse effects associated with 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact the Poison Control Center immediately.

Patients must be instructed to use the product only as directed and to refrain from using it in any other manner. Those with a known allergy to aspirin or salicylates should be cautioned against using this product.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if they experience skin irritation or redness, or if pain persists for more than seven days. Additionally, they should seek medical advice if symptoms resolve and then recur within a few days.

While using this product, patients should avoid contact with their eyes and mucous membranes. They should also be advised not to apply the product to wounds, damaged, or irritated skin. It is important to instruct patients not to bandage the area tightly or use a heating pad in conjunction with the product. Furthermore, patients should be reminded not to use the product one hour prior to bathing or within thirty minutes after bathing.

Storage and Handling

The product is supplied in a configuration that requires careful handling to maintain its integrity. It is essential to close the cap tightly after each use to prevent contamination and ensure the product remains effective.

For optimal storage, the product should be kept in a cool place, away from direct sunlight and heat sources. This will help preserve its quality and efficacy throughout its shelf life.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, consultation with a healthcare professional is advised prior to use, and the product is not intended for children under two years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is crucial to keep the product out of reach of children to prevent accidental poisoning; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Ultra 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 Ultra 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.

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.