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Valtrum Soothing Topical Analgesic

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 25 mg/1 g
  • Menthol 25 mg/1 g
  • Methyl Salicylate 100 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 2015
Label revision date
September 28, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 25 mg/1 g
  • Menthol 25 mg/1 g
  • Methyl Salicylate 100 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 2015
Label revision date
September 28, 2020
Manufacturer
Laboratorios Quantium LLC
Registration number
part348
NDC root
75849-300
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 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 rheumatism, muscle strains, sprains, bruises, and stiffness in the neck and shoulders. By targeting these discomforts, it aims to improve your overall comfort and 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 discomfort associated with conditions like rheumatism, muscle strains, sprains, bruises, and stiffness in the neck and shoulders.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to alleviate those bothersome aches.

Dosage and Administration

To use this medication, apply it directly to the area of your skin that is affected. It's important not to rub or massage the area after application, as this can interfere with how the medication works. You’ll notice that your skin absorbs the medication quickly, which is a good sign that it’s getting to work.

For best results, you should apply the medication every 6 hours, but remember not to exceed 4 applications in a single day. Following these guidelines will help ensure that you get the most benefit from your treatment.

What to Avoid

You should avoid using this medication if you are pregnant or nursing, as well as if you are a child under 8 years of age. Additionally, do not apply external heat, such as a heating pad, while using this medication, as it can lead to unwanted effects.

It's important to be aware that this medication may carry risks of abuse or misuse, and there are concerns regarding dependence (a condition where your body becomes reliant on a substance). Always follow these guidelines to ensure your safety and well-being.

Side Effects

You should be aware that this product is for external use only and is not recommended for children under 8 years of age, pregnant or nursing individuals, or when using a heating pad or applying external heat.

If you experience skin redness or excessive irritation, notice that your condition worsens, or if your symptoms persist for more than 7 days or return shortly after improvement, it’s important to stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes, and do not use it on wounds or damaged skin. Make sure to follow the directions carefully and avoid tightly bandaging the area where you apply it. It is not suitable for children under 8 years old, and if you are pregnant or nursing, you should not use it. Additionally, do not use it with a heating pad or apply any external heat.

If you notice any skin redness or excessive irritation, or if your condition worsens, stop using the product and consult your doctor. You should also reach out to your healthcare provider if your symptoms last more than 7 days or if they improve and then return within a few days.

In case of accidental ingestion, seek emergency 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. Contact a medical professional or call a Poison Control Center immediately for guidance.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical attention. Remember, acting fast can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or nursing, it is important to avoid using this medication. The potential risks to your baby during pregnancy or while breastfeeding are significant, and it is best to prioritize their health and safety. Always consult with your healthcare provider for guidance on safe treatment options during this time.

Lactation Use

If you are pregnant or breastfeeding, it is important to avoid using this medication. Using it during these times could pose risks to you and your baby. Always consult with your healthcare provider for guidance on safe options while nursing. Your health and your baby's well-being are the top priorities.

Pediatric Use

It is important to note that this medication should not be used in children under 8 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

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 considering this medication, it’s important to consult with a healthcare provider. 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 (issues with liver function).

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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, away from any heat sources or flames. This helps maintain its integrity and performance.

When handling the product, pay attention to the bottle's imprinted seal around the neck. This seal is designed to protect you; do not use the product if the seal is missing, broken, or destroyed, as this could indicate that the product has been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication directly to the affected area every 6 hours, but be careful not to use it more than 4 times a day. If you have any questions about how to use the medication or its effects, consult your healthcare provider for guidance.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints associated with conditions like rheumatism, muscle strain, sprains, bruises, and neck and shoulder stiffness.

How should I apply the drug?

You should apply the drug directly to the affected area every 6 hours, but do not use more than 4 times daily. Avoid rubbing or massaging the area.

Are there any age restrictions for using this drug?

Do not use this drug in children under 8 years of age.

Can I use this drug if I am pregnant or nursing?

No, you should not use this drug if you are pregnant or nursing.

What should I do if I experience skin irritation?

If you experience skin redness or excessive irritation, or if your condition worsens, stop using the drug and consult your doctor.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin. Do not use with a heating pad or apply external heat.

How should I store this drug?

Store the drug at room temperature, away from heat and flame, and ensure the tamper-evident seal is intact.

Packaging Info

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

Packaging configurations for Valtrum Soothing Topical Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients, which are insert inactive ingredients here.

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 rheumatism, muscle strain, sprains, bruises, and neck and shoulder stiffness.

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

Dosage and Administration

The medication should be applied directly to the affected area. It is important to avoid rubbing or massaging the application site, as the skin will absorb the medication quickly. The recommended frequency of application is every 6 hours, with a maximum of 4 applications per day.

Contraindications

Use is contraindicated in the following situations:

  • In children under 8 years of age, due to safety concerns related to efficacy and potential adverse effects.

  • During pregnancy or nursing, as the effects on fetal and infant health are not established.

  • In conjunction with heating pads or external heat applications, as this may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. It is imperative that this product is utilized strictly as directed to ensure safety and efficacy. Care should be taken to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation. Additionally, the product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly after application.

This product is contraindicated for use in children under 8 years of age, as well as in individuals who are pregnant or nursing. The application of this product in conjunction with a heating pad or any external heat source is also not recommended, as it may increase the risk of adverse effects.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: skin redness or excessive irritation, worsening of the condition, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

For external use only, this product is contraindicated in children under 8 years of age, and it should not be used by individuals who are pregnant or nursing. Additionally, it should not be applied in conjunction with a heating pad or any external heat source.

Patients are advised to discontinue use and consult a healthcare professional if they experience skin redness or excessive irritation. Furthermore, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Valtrum Soothing Topical Analgesic.
Details

Pediatric Use

Pediatric patients under 8 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and caution is advised when considering treatment options for younger children.

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

Pregnancy

Pregnant patients and nursing mothers should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in this population remains unclear. Therefore, healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding.

Lactation

Lactating mothers should not use this medication while nursing. There is no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is advised, and alternative treatments should be considered for lactating mothers.

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. 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 drug. 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or nursing individuals due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available 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 inform patients that this product is not recommended for use in children under 8 years of age and should not be used by individuals who are pregnant or nursing.

Patients should be cautioned against using the product in conjunction with a heating pad or applying external heat, as this may lead to adverse effects. They should be instructed to discontinue use and consult a doctor if they experience skin redness or excessive irritation. Additionally, patients should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Furthermore, patients should be instructed not to bandage the area tightly after application.

Storage and Handling

This product is supplied in a bottle with an imprinted tamper-evident seal around the neck. It is essential to inspect the seal prior to use; do not use the product if the seal is missing, broken, or destroyed.

The product should be stored at room temperature, away from heat and flame, to ensure its integrity and effectiveness. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

Patients should apply the medication directly to the affected area every 6 hours, ensuring that it is not used more than 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Valtrum Soothing 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 Valtrum Soothing 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.

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.