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Valtrum Immediate Action Topical Analgesic

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Active ingredients
  • Menthol, Unspecified Form 3 g/100 g
  • Camphor (synthetic) 3 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Cream
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
December 21, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 3 g/100 g
  • Camphor (synthetic) 3 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Cream
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
December 21, 2023
Manufacturer
LABORATORIOS QUANTIUM LLC
Registration number
M017
NDC root
75849-897
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 helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. 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 various conditions, including simple backache, arthritis, strains, bruises, and sprains.

You can rely on this treatment to ease discomfort associated with these common issues, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage your symptoms effectively.

Dosage and Administration

If you are an adult or a child aged 18 years or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

If you are caring for a child under 18 years of age, it’s important to consult a doctor before using this medication. They can provide the appropriate advice and dosage recommendations for younger patients. Always prioritize safety and follow professional guidance when it comes to medication for 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, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only use it externally and avoid contact with your eyes and mucous membranes. If you experience excessive skin irritation, discontinue use immediately. Additionally, do not apply the product to wounds or damaged skin, and avoid tight bandaging.

If your condition worsens, symptoms persist for more than seven days, or if they clear up and return shortly after, stop using the product and consult a doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before use. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes and mucous membranes. Use it exactly as directed, and be cautious: if you experience excessive skin irritation, stop using it immediately. When applying, do not bandage tightly or use it on wounds or damaged skin.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by calling your local 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. Your safety is the top priority, so act quickly if you suspect an overdose.

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 have a child under 18 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your children.

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, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 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. Always keep the lid tightly closed when not in use to protect the contents from contamination and environmental factors. Following these simple storage guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 18 and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 18 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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 simple backache, arthritis, strains, bruises, and sprains.

How should adults and children 18 years and older use this drug?

Adults and children 18 years of age and older should apply it to the affected area not more than 3 to 4 times daily.

What should children under 18 years of age do before using this drug?

Children under 18 years of age should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

Use the drug for external use only, avoid contact with eyes and mucous membranes, and do not bandage tightly or apply to wounds or damaged skin.

What should I do if I swallow this drug?

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

What should I do if my symptoms persist?

Stop use and ask a doctor if conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store this drug?

Store the drug in a cool, dry place away from direct sunlight and keep the lid tightly closed.

Packaging Info

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

Packaging configurations for Valtrum Immediate Action Topical Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

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 18 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

For children under 18 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

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

Warnings and Precautions

For external use only, this product should be applied strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or adverse reactions. In the event of excessive skin irritation, the use of the product should be discontinued immediately.

When utilizing this product, it is essential to refrain from tightly bandaging the area of application and to avoid applying it to wounds or damaged skin. Healthcare professionals should advise patients to stop use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

Special caution is warranted for individuals who are pregnant or breastfeeding; they should seek guidance from a healthcare professional prior to use. Additionally, this product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with eyes and mucous membranes. It is imperative that patients do not use the product otherwise than as directed. Caution is advised; patients should discontinue use if excessive irritation of the skin develops.

When using this product, patients are advised against bandaging tightly and should not apply it to wounds or damaged skin. If conditions worsen or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients should stop use and consult a doctor.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately. Additionally, pregnant or breastfeeding patients are encouraged to consult a health professional before use to ensure safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Valtrum Immediate Action Topical Analgesic (camphor, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Valtrum Immediate Action Topical Analgesic.
Details

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional prior to use. It is essential to evaluate the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual clinical circumstances.

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 those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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 available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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 immediately or contact a Poison Control Center without delay. This guidance is crucial to ensure the safety and well-being of patients and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, away from direct sunlight, to maintain its efficacy. Additionally, the container must be kept tightly closed to prevent contamination and degradation. Proper adherence to these storage conditions is crucial for ensuring the product's quality and longevity.

Additional Clinical Information

Patients aged 18 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 18 years of age, it is recommended that a clinician be consulted prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Valtrum Immediate Action 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 Immediate Action 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.