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Ultra Strength Pain Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Camphor (synthetic) 4 g/100 g
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
June 25, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 4 g/100 g
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Spray
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 2014
Label revision date
June 25, 2018
Manufacturer
Product Quest Mfg
Registration number
part348
NDC root
64048-5114
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 temporarily relieve minor pain associated with various conditions, including arthritis, simple backache, muscle strains, bruises, and muscle sprains. It works by targeting the discomfort you may feel from these common ailments, helping you to feel more comfortable and manage your pain effectively.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various types of discomfort, including pain from arthritis, simple backaches, muscle strains, bruises, and muscle sprains.

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 manage these specific types of minor pain.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 2 years and older, you can spray it directly onto the affected area. You should apply it no more than 3 to 4 times a day for the best results.

If your child is under 2 years old, it's important to consult a doctor before using this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging tightly or using it with a heating pad, as these practices can cause irritation or other adverse effects.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, please consult with a healthcare professional.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes or on mucous membranes, and do not apply it to any wounds or damaged skin. Additionally, refrain from tightly bandaging the area or using a heating pad while using this product. Always follow the directions provided.

If your condition worsens, or if your symptoms persist for more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes, mucous membranes, or any wounds and damaged skin. It is important to use the product as directed and not to apply it tightly or with a heating pad. Remember that this product is flammable; keep it away from fire, flames, and high temperatures (above 120˚F). Do not store it in places that exceed 104˚F, and never puncture or incinerate the container.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if symptoms improve and then return within a few days.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the spray to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, always consult with a healthcare provider before starting a new medication. They can help determine the best approach based on individual health needs and any other medications being taken.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. They can monitor for any potential side effects and make recommendations tailored to your situation.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure your safety and the proper use of the product, it's important to store it correctly. Keep it away from fire or flames, and avoid storing it in places where temperatures exceed 104°F (40°C) for long periods. Never store it at temperatures above 120°F (49°C), as this can compromise its integrity.

When handling the product, remember that it is under pressure, so do not puncture or incinerate it. Additionally, avoid using it while smoking or near any heat sources or flames to prevent accidents. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can use this medication topically by spraying it on the affected area. For adults and children aged 2 years and older, apply it no more than 3 to 4 times a day. If your child is under 2 years old, it's important to consult a doctor before use.

If you are pregnant or breastfeeding, be sure to ask a health professional for advice before using this product.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, bruises, and muscle sprains.

How should I use this drug?

Shake well before use. Spray on the affected area, not more than 3 to 4 times daily for adults and children 2 years of age and older. Consult a doctor for children under 2 years.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days or recur within a few days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What precautions should I take when using this drug?

Keep away from fire or flame, avoid long-term storage above 104°F, and do not store at temperatures above 120°F. Do not use while smoking or near heat.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Packaging Info

Below are the non-prescription pack sizes of Ultra Strength Pain Relief (camphor 4%, menthol 10%, methyl salicylate 30%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ultra Strength Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Ultra Strength Pain Relief, 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 specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, bruises, and muscle sprains.

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

Dosage and Administration

The product should be shaken well prior to use. For adults and children aged 2 years and older, the recommended administration is to spray the product on the affected area, not exceeding 3 to 4 times daily. For children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging or in conjunction with heating pads, as this may increase the risk of skin irritation or other complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it is imperative to keep it away from fire or flame. Long-term storage above 104˚F should be avoided, and the product must not be punctured or incinerated, as it contains contents under pressure. Additionally, storage at temperatures exceeding 120˚F is prohibited. Users should refrain from using the product while smoking or in proximity to heat or flame.

General precautions include avoiding contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin. It is also advised not to bandage tightly or use in conjunction with a heating pad. The product must be used only as directed to ensure safety and efficacy.

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

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging tightly or using the product in conjunction with a heating pad. The product should be used only as directed to minimize the risk of adverse reactions.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to stop use and consult a doctor. These precautions are essential to ensure the safe and effective use of the product.

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 Ultra Strength Pain Relief (camphor 4%, menthol 10%, methyl salicylate 30%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ultra Strength Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to spray on the affected area no more than 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

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

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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 maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a healthcare provider if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be informed to stop using the product and consult a doctor if symptoms resolve and then recur within a few days.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes while using this product. Patients must also be cautioned against applying the product to wounds or damaged skin. Furthermore, it is essential to advise patients not to bandage the area tightly or use the product in conjunction with a heating pad. Finally, patients should be reminded to use the product only as directed to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that includes specific National Drug Code (NDC) numbers, which should be referenced for accurate identification.

For optimal storage and handling, it is essential to keep the product away from fire or flame. Long-term storage should be avoided at temperatures exceeding 104°F, and it is critical not to store the product at temperatures above 120°F. The container must not be punctured or incinerated, as the contents are under pressure. Additionally, the product should not be used while smoking or in proximity to heat or flame to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a healthcare provider is advised prior to use. Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding before using the product.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ultra Strength Pain Relief, 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 Strength Pain Relief, 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.