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Utaspray

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Active ingredients
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 50 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
November 21, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 100 mg/1 mL
  • Methyl Salicylate 50 mg/1 mL
Other brand names
Dosage form
Liquid
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 2022
Label revision date
November 21, 2023
Manufacturer
Big 5 Nutrition LLC
Registration number
M017
NDC root
82198-0008
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

You can use this medication for temporary relief of joint and muscle aches and pains. It is particularly helpful for conditions such as sprains and strains, inflammation, and mild bruises. This means that if you're experiencing discomfort in your muscles or joints, this drug may provide you with the relief you need to feel more comfortable.

Uses

You can use this medication for temporary relief from joint and muscle aches and pains. This includes discomfort caused by sprains, strains, inflammation, and mild bruises. If you're dealing with any of these issues, this medication may help ease your symptoms and improve your comfort.

Dosage and Administration

Before using the treatment, make sure the area of your skin is clean and dry. Once you're ready, spray the treatment directly onto the affected skin. If you prefer, you can gently rub it in for better absorption.

You can use this treatment up to 10 times a day if you are an adult or a child over the age of 2. Just remember to follow these steps each time to ensure the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use this medication without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so make sure to apply it as directed. Avoid getting it in your eyes or on mucous membranes, and do not use it on open wounds or any irritated or broken skin. If you notice a skin rash or irritation, or if your condition worsens, stop using the product immediately.

If you are pregnant or breastfeeding, it's a good idea to consult your doctor before using this product to ensure it's safe for you.

Warnings and Precautions

This product is for external use only, so make sure to apply it as directed. Avoid getting it in your eyes or on mucous membranes, and do not use it on open wounds or any irritated or broken skin. If you notice a skin rash or irritation, or if your condition worsens, stop using the product and call your doctor.

If you are pregnant or breastfeeding, it's important to consult your doctor before using this product. Additionally, keep it out of reach of children to ensure their safety.

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, 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. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding any medications you may consider while nursing.

Pediatric Use

You can use this medication for children over the age of 2, and it is safe for them to take it up to 10 times a day, just like adults. However, always ensure you follow the recommended dosage and consult with your child's healthcare provider if you have any questions or concerns about its use.

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 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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes 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 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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. Before using it, make sure to shake it well to mix the contents thoroughly. After each use, remember to close the cap tightly to maintain its effectiveness and prevent contamination. Following these simple steps will help you use the product safely and effectively.

Additional Information

You can use this medication topically, which means you apply it directly to the skin. It is safe for both adults and children over the age of 2, and you can use it up to 10 times a day if needed. If you have any questions about how to use it or its effects, be sure to consult with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of joint and muscle aches and pains, including sprains, strains, inflammation, and mild bruises.

How should I apply this drug?

You should spray the treatment directly onto clean and dry skin and gently rub it in if desired.

How often can I use this drug?

You may use this drug up to 10 times per day in adults and children over the age of 2.

Are there any warnings I should be aware of?

Yes, this drug is for external use only. Avoid contact with eyes or mucous membranes, and do not use on open wounds or irritated skin.

What should I do if I experience skin irritation?

You should discontinue use if a skin rash or irritation develops or if your condition worsens.

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

You should consult your doctor before using this drug if you are pregnant or breastfeeding.

How should I store this drug?

Store the drug at room temperature and shake well before use. Make sure to close the cap tightly after use.

Packaging Info

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

Packaging configurations for Utaspray.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of joint and muscle aches and pains, including but not limited to sprains and strains, inflammation, and mild bruises.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The application area should be cleaned and dried prior to treatment. The product is to be sprayed directly onto the skin. If desired, the treated area may be gently rubbed in to enhance absorption.

For both adults and children over the age of 2, the treatment may be administered up to 10 times per day. It is important to adhere to this frequency to ensure optimal efficacy while minimizing the risk of adverse effects.

Contraindications

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

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals must advise patients to avoid contact with the eyes or mucous membranes, as this may lead to adverse reactions.

It is imperative that this product not be applied to open wounds or on irritated or broken skin. Should any skin rash or irritation develop, or if the condition worsens, the use of this product should be discontinued immediately.

Patients who are pregnant or breastfeeding are advised to consult their healthcare provider prior to use to assess any potential risks.

Additionally, it is crucial to keep this product out of the reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the product is for external use only and must be used strictly as directed. It is important to avoid contact with the eyes or mucous membranes. The product should not be applied to open wounds or on irritated or broken skin.

In clinical practice, patients are advised to discontinue use if a skin rash or irritation develops, or if the condition worsens. Additionally, it is recommended that individuals consult their doctor prior to use if they are pregnant or breastfeeding. These precautions are essential to ensure the safety and well-being of patients using the product.

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 Utaspray (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Utaspray.
Details

Pediatric Use

Pediatric patients over the age of 2 may use the medication up to 10 times per day. There are no specific dosage adjustments indicated for this age group. Safety and efficacy in children under the age of 2 have not been established. Healthcare professionals should exercise caution when prescribing this medication to pediatric patients, ensuring that the benefits outweigh any potential risks.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when making recommendations.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety and well-being of both the mother and the nursing infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that requires careful handling to ensure its efficacy. It should be stored at room temperature, away from direct sunlight and moisture. Prior to each use, it is essential to shake the container well to ensure proper mixing of the contents. After use, the cap must be closed tightly to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically and may be used up to 10 times per day in adults and children over the age of 2. 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 Utaspray, 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 Utaspray, 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.