ADD CONDITION
Pain Relief Cream Extra Strength
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This product has been discontinued
- Active ingredients
- Capsaicin 0.01 g/100 g
- Menthol 5 g/100 g
- Camphor (natural) 4 g/100 g
- Methyl Salicylate 20 g/100 g
- Other brand name
- 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 2019
- Label revision date
- January 13, 2020
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Capsaicin 0.01 g/100 g
- Menthol 5 g/100 g
- Camphor (natural) 4 g/100 g
- Methyl Salicylate 20 g/100 g
- Other brand name
- 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 2019
- Label revision date
- January 13, 2020
- Manufacturer
- Everyday Medical LLC
- Registration number
- part348
- NDC root
- 72982-1901
- Drug Information (PDF)
- Prescribing information, PDF file
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, sprains, and cramps. It works by targeting the pain signals in your body, helping you feel more comfortable during everyday activities. If you're experiencing any of these types of pain, this drug may provide the relief you need.
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, sprains, or cramps, 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, making it a safer option for those concerned about such risks.
Dosage and Administration
It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.
If the patient is a child under 12 years old, it's essential to consult a doctor before use. This will help ensure that the treatment is appropriate and safe for younger patients. Always follow your healthcare provider's instructions for the best results.
What to Avoid
It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.
Side Effects
When using this product, it's important to follow the directions carefully to avoid potential issues. This product is for external use only, so do not apply it to wounds or any damaged, broken, or irritated skin. Avoid contact with your eyes and mucous membranes, and do not use it with a heating pad or bandage tightly. If you experience a severe burning sensation, stop using it right away.
You should also stop using the product and consult a doctor if your condition worsens, if you notice any redness, or if irritation develops. Keeping an eye on these reactions can help ensure your safety while using the product.
Warnings and Precautions
This product is for external use only, so please use it as directed. Avoid wrapping the area tightly or using a heating pad while applying it. Be careful to keep it away from your eyes and any mucous membranes, and do not apply it to wounds or any skin that is broken, damaged, or irritated. If you experience a severe burning sensation, stop using the product immediately.
You should stop using this product and contact your doctor if your condition worsens, if you notice any redness, or if irritation develops. If the product is swallowed, seek emergency medical help or contact a Poison Control Center right away.
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
When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns outlined in the information provided. This means that the effects of the medication on pregnant individuals and their developing babies are not clearly defined.
If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting any new medication. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.
As a precaution, you may want to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your nursing infant. Always prioritize your health and your baby's well-being when making decisions about medication while breastfeeding.
Pediatric Use
It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. For adults and children aged 12 and older, the medication can be applied to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old, you should consult a doctor before use to ensure their safety.
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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.
Renal Impairment
If you have kidney issues, 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.
Hepatic Impairment
If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support 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 has a complete understanding of your health and can provide the best care possible.
Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your safety and well-being are the top priority, and discussing your medications helps to avoid any potential issues.
Storage and Handling
To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once opened, please remember to discard the product, as it should not be reused. Following these guidelines will help maintain the product's effectiveness and safety for your use.
Additional Information
You should apply this medication topically to the affected area. For adults and children aged 12 and older, it can be used 3 to 4 times a day. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences.
FAQ
What minor pains does this drug relieve?
This drug temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps.
How should I use this drug?
Adults and children 12 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 12 should consult a doctor.
Are there any contraindications for this drug?
No contraindications are listed for this drug.
What should I do if I accidentally swallow this drug?
If swallowed, get medical help or contact a Poison Control Center right away.
What precautions should I take when using this drug?
Use only as directed, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin. If severe burning occurs, discontinue use immediately.
What should I do if my condition worsens while using this drug?
Stop use and ask a doctor if your condition worsens, if redness is present, or if irritation develops.
Is this drug safe to use during pregnancy or while nursing?
No specific information is provided regarding use during pregnancy or nursing.
How should I store this drug?
Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.
Packaging Info
Below are the non-prescription pack sizes of Pain Relief Cream Extra Strength (methyl salicylate, menthol, camphor, capsaicin cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cream |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Pain Relief Cream Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No relevant information is available for SPL code 34089-3.
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, sprains, and cramps.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Healthcare professionals should instruct patients to use the medication only as directed. For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.
For children under the age of 12 years, it is essential to consult a doctor prior to use to determine appropriate dosing and administration.
Contraindications
Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.
Warnings and Precautions
For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging tightly or using in conjunction with a heating pad, as these practices may exacerbate adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, as such exposure can lead to significant irritation. Additionally, the product should not be applied to wounds or any areas of damaged, broken, or irritated skin. In the event of a severe burning sensation, the user should discontinue use immediately.
Healthcare professionals should advise patients to stop using the product and seek medical attention if any of the following occur: worsening of the condition, the presence of redness, or the development of irritation. These symptoms may indicate an adverse reaction that requires further evaluation.
In cases of accidental ingestion, it is critical to obtain emergency medical assistance or contact a Poison Control Center without delay. Prompt action is essential to mitigate potential health risks associated with swallowing the product.
Side Effects
Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid bandaging tightly or using the product in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or areas of damaged, broken, or irritated skin.
In clinical use, if patients experience a severe burning sensation, they are advised to discontinue use immediately. Additionally, patients should stop using the product and consult a healthcare professional if their condition worsens, if redness is observed, or if any irritation develops. These precautions are essential to ensure the safe and effective use of the product.
Drug Interactions
There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Pain Relief Cream Extra Strength (methyl salicylate, menthol, camphor, capsaicin cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cream |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.
For dosing, adults and children aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor prior to use.
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
Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.
Lactation
There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.
Renal Impairment
There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.
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 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 implement supportive care measures, 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 the management of the overdose effectively.
Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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. It is important to emphasize the potential risks associated with swallowing the medication. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure patient safety and appropriate response in case of accidental exposure.
Storage and Handling
The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.
To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.
Additional Clinical Information
The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.
Drug Information (PDF)
This file contains official product information for Pain Relief Cream Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.