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Novum

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Active ingredient
Menthol 0.5 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
April 7, 2025
Active ingredient
Menthol 0.5 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2015
Label revision date
April 7, 2025
Manufacturer
NOVUM SOLUTIONS INC
Registration number
M017
NDC root
69574-005

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Drug Overview

Novum APR is a topical burn cream designed to provide pain relief and cooling effects for various skin irritations. It is particularly useful for alleviating discomfort around aching joints or muscle pain. To use it effectively, you simply spray Novum APR generously on the affected area and allow it to dry without rubbing, applying it as often as needed for relief.

Uses

If you're experiencing deep, penetrating pain in your joints or muscles, you can use Novum APR for relief. Simply spray it generously on the affected area of your skin and let it dry without rubbing. You can apply it as often as you need to help manage your discomfort.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe option for many users.

Dosage and Administration

To use this product, apply it directly to the areas of your skin that are affected. Make sure to let it dry completely without rubbing it in. You can use this product as often as you need, but it's important to follow the directions provided to ensure safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. This means that, based on the information provided, there are no particular conditions or risks that you need to avoid when considering this treatment. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your medication.

Side Effects

You should be aware that this product is not intended for use on children under 2 years old unless directed by a doctor. It's important to avoid contact with your eyes and remember that this product is for external use only. If you experience any irritation that continues, or if your condition worsens or does not improve after 7 days, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is not meant for children under 2 years old unless a doctor specifically directs its use. It is for external use only, so please avoid getting it in your eyes.

If you experience any irritation that doesn't go away, stop using the product and talk to your doctor. Additionally, if your condition worsens, or if your symptoms last more than 7 days or come back shortly after improving, discontinue use and consult your doctor for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

When it comes to breastfeeding, it's important to be aware that the information provided does not specifically address nursing mothers or lactation (the process of producing milk). If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider about any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Your safety and your baby's well-being are the top priorities, so don't hesitate to ask questions and seek guidance.

Pediatric Use

It's important to be cautious when considering this medication for your child. This product is not intended for use in children under 2 years old unless specifically directed by a doctor. If your child is younger than this age, please consult with a healthcare professional before using the medication to ensure their safety and well-being. Always follow your doctor's guidance regarding dosage and usage for children.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 plan.

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 remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best results with your external analgesic (a product used to relieve pain on the skin), it's important to store it in a cool, dry place away from direct sunlight. This helps maintain its effectiveness. When handling the product, make sure to wash your hands before and after use to prevent any contamination and to ensure safety.

If you have any specific components that come with the analgesic, such as applicators or packaging, be sure to follow any additional instructions provided for their use or disposal. Always check the product for any specific temperature ranges or storage conditions mentioned on the label to keep it in optimal condition.

Additional Information

No further information is available.

FAQ

What is Novum APR?

Novum APR is a topical burn cream that provides pain relief and cooling effects.

How should I use Novum APR?

Spray Novum APR generously on the skin around aching joints or muscle pain, allowing it to dry without rubbing. You can apply it as often as needed.

Are there any contraindications for using Novum APR?

No contraindications are listed for Novum APR in the provided information.

Can I use Novum APR on children?

Novum APR is not intended for use on children under 2 years old unless directed by a doctor.

What should I do if I experience irritation while using Novum APR?

If irritation develops and persists, you should discontinue use and consult a doctor.

Is Novum APR safe to use around the eyes?

You should avoid contact with the eyes when using Novum APR.

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

If your condition worsens or symptoms persist for more than 7 days, or if they clear up and occur again within a few days, discontinue use and consult a doctor.

Are there any known drug interactions with Novum APR?

No specific drug interactions are mentioned for Novum APR.

Is there any information about using Novum APR during pregnancy or lactation?

The provided information does not address the use of Novum APR during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Novum.
Details

Drug Information (PDF)

This file contains official product information for Novum, 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 SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for cooling, deep-penetrating pain relief. It is recommended to spray Novum APR generously on the skin surrounding aching joints or areas of muscle pain, allowing it to dry without rubbing. The application may be repeated as often as needed to achieve the desired relief.

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

Dosage and Administration

This product should be applied topically to the affected areas. It is important to allow the application to dry completely without rubbing the area. The frequency of application can be as often as needed, but it is essential to use the product only as directed.

Contraindications

There are no contraindications listed for this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The product is not intended for use in children under 2 years of age unless specifically directed by a healthcare professional. It is crucial to avoid contact with the eyes during application. This product is designated for external use only.

In the event that irritation develops and persists, it is recommended to discontinue use immediately and seek consultation from a healthcare provider. Additionally, if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of the product should be discontinued, and a healthcare professional should be consulted for further evaluation and management.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is not intended for use on children under 2 years old unless directed by a doctor. Additionally, contact with the eyes should be avoided, and the product is for external use only.

In clinical practice, if irritation develops and persists, patients are advised to discontinue use and consult a doctor. Furthermore, if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that patients discontinue use and seek medical advice.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Novum (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Novum.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication unless specifically directed by a healthcare professional. Caution is advised when considering treatment options for this age group, and healthcare providers should evaluate the risks and benefits before prescribing.

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

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

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

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with unauthorized access to the medication, ensuring that patients understand the necessity of proper storage.

Storage and Handling

The external analgesic is supplied in various package configurations. It is essential to store the product in a cool, dry place, maintaining a temperature range of 20°C to 25°C (68°F to 77°F). The product should be kept in its original container to protect it from moisture and light. Special handling precautions should be observed to prevent contamination and ensure the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Novum, 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 Novum, 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.