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Ultra Strength Pain Relief

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 4 g/100 mL
  • Menthol 10 g/100 mL
  • Methyl Salicylate 30 g/100 mL
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 mL
  • Menthol 10 g/100 mL
  • Methyl Salicylate 30 g/100 mL
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
Car One
Registration number
part348
NDC root
41520-317
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 backaches, 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

You can use this medication to temporarily relieve minor pain from various conditions. If you're dealing with arthritis, simple backaches, muscle strains, bruises, or muscle sprains, this medication may help ease your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard. However, always consult with your healthcare provider for personalized advice and to ensure it's appropriate for your situation.

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 on 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 medication safely to ensure your well-being. You should avoid applying it to any wounds or damaged skin, as this can lead to complications. Additionally, do not bandage the area tightly or use it in conjunction with a heating pad, as these practices may cause adverse effects.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for further guidance.

Side Effects

When using this product, it's important to apply it only to the skin and avoid contact with your eyes and mucous membranes. Do not use it on wounds or damaged skin, and refrain from tightly bandaging the area or using a heating pad. 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, stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid using it on wounds or damaged skin. It is flammable, so keep it away from fire, flames, and heat sources. Do not store it at temperatures above 120°F, and avoid long-term storage above 104°F. Remember not to puncture or incinerate the container, as it is under pressure. Always use the product as directed and avoid contact with your eyes and mucous membranes.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your condition worsens, or if symptoms last more than 7 days or 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 there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

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 not to use it 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, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 change 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 situation. They can help monitor your kidney health and make any necessary adjustments 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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 safety and effectiveness of your product, store it in a cool place, keeping the temperature below 120°F (49°C). It's important to avoid long-term storage at temperatures above 104°F (40°C) to maintain its integrity. Always keep the product away from fire or flames, as it is sensitive to heat.

When handling the product, remember not to puncture or incinerate it, as the contents are under pressure and could pose a safety risk. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, spraying it on the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use.

If you are pregnant or breastfeeding, make sure to speak with a health professional before using this product to ensure it is safe for you.

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 and 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?

Yes, this product is for external use only, flammable, and you should avoid contact with eyes and mucous membranes. 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 clear up and occur again within a few days.

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

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

What should I do in case of accidental ingestion?

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

How should I store this drug?

Store at temperatures below 120°F and avoid long-term storage above 104°F. Keep away from fire or flame.

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 text.

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 medication should be shaken well before use. For adults and children aged 2 years and older, it is recommended to spray the medication on the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to administration.

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 should not exceed 104˚F, and the product must not be punctured or incinerated, as it contains contents under pressure. Additionally, it should not be stored at temperatures above 120˚F, and usage while smoking or near heat or flame is strictly prohibited.

General precautions include avoiding contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it is advised not to bandage tightly or use in conjunction with a heating pad. It is essential to use this product 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. It is crucial to use the product 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

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 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 prescribing 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 substance involved, the amount taken, and the time of ingestion, 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product and seek medical advice if symptoms resolve and then recur within a few days.

Providers should emphasize the importance of avoiding contact with the eyes and mucous membranes while using this product. Additionally, patients should be cautioned against applying the product to wounds or damaged skin. It is crucial to inform patients not to bandage the area tightly or use the product in conjunction with a heating pad. Finally, healthcare providers should remind patients to use the product only as directed to ensure safety and efficacy.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It is essential to store the product at temperatures below 120°F to maintain its integrity. Long-term storage should be avoided at temperatures exceeding 104°F.

Additionally, the product must be kept away from fire or flame to prevent any hazardous situations. It is crucial not to puncture or incinerate the container, as the contents are under pressure, which could lead to dangerous outcomes. Proper adherence to these storage and handling guidelines is necessary 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.