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Painzone
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This product has been discontinued
- Active ingredients
- Camphor, (-) - 30 mg/1 g
- Menthol 120 mg/1 g
- Methyl Salicylate 200 mg/1 g
- Other brand names
- 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 2016
- Label revision date
- February 12, 2018
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Camphor, (-) - 30 mg/1 g
- Menthol 120 mg/1 g
- Methyl Salicylate 200 mg/1 g
- Other brand names
- 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 2016
- Label revision date
- February 12, 2018
- Manufacturer
- MedZone Products LLC
- Registration number
- part348
- NDC root
- 70338-641
- Drug Information (PDF)
- Prescribing information, PDF file
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If you are a consumer or patient please visit this version.
Drug Overview
This medication is designed to temporarily relieve minor aches and pains in muscles and joints. It can be particularly helpful for discomfort associated with strains, sprains, arthritis, and simple backaches. The drug works by providing penetrating pain relief, helping you feel more comfortable and active throughout your day.
Uses
If you're dealing with minor aches and pains in your muscles and joints, this medication can help. It temporarily relieves discomfort caused by strains, sprains, arthritis, and simple backaches.
In addition to easing these common pains, it also offers penetrating pain relief, which means it works deeply to help alleviate your discomfort. Whether you're recovering from an injury or managing chronic pain, this medication can provide the support you need.
Dosage and Administration
If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.
For children under 2 years of age, it’s important to consult a physician (doctor) before using the medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.
What to Avoid
It's important to use this product safely to avoid any potential issues. You should never apply it in or near your eyes, as this can cause irritation or harm. Additionally, avoid using large amounts, especially on raw or blistered skin, as this could lead to adverse effects. Always be cautious and ensure that the product does not come into contact with your eyes during use.
Side Effects
When using this product, it's important to avoid contact with your eyes, as it is meant for external use only. If you experience an allergic reaction (a serious response by your immune system), or if your condition worsens or does not improve within 7 days, you should stop using the product and consult a physician. Additionally, if your symptoms clear up and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other worsening symptoms, seek medical advice.
To ensure safety, do not apply the product in or near your eyes, and avoid using it in large amounts, especially on raw or blistered skin.
Warnings and Precautions
This product is for external use only, so please avoid applying it to your eyes. If you experience any signs of an allergic reaction, such as rash or difficulty breathing, stop using the product and call your doctor right away. Additionally, if your condition worsens or does not improve within 7 days, or if symptoms clear up and then return within a few days, you should also contact your doctor. Be alert for any redness, irritation, swelling, or pain that begins or increases, and seek medical advice if these occur.
In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center immediately. Your safety is a priority, so please take these precautions seriously.
Overdose
If you or someone else has swallowed too much of a medication, it’s important to seek medical help right away. You can do this by contacting a Poison Control Center or going to the nearest emergency room.
Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help immediately. Remember, acting quickly can make a significant difference in the outcome.
Pregnancy Use
When it comes to using PainZone external analgesic cream during pregnancy, there is currently no information available about its safety or effects. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.
Lactation Use
If you are breastfeeding, you can use PainZone external analgesic cream without specific warnings or recommendations against it. Currently, there is no information available about whether the ingredients in this cream pass into breast milk or if they pose any risks to your baby.
As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products while nursing.
Pediatric Use
If your child is under 2 years old, it's important to consult a physician (doctor) before using this medication. For children aged 2 years and older, you can apply the medication 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
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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.
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 remember that even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.
Storage and Handling
To ensure the best performance of your product, store it at room temperature. It's important to keep it away from extreme temperatures, both hot and cold, as these can affect its effectiveness.
When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure your product remains safe and effective for use.
Additional Information
No further information is available.
FAQ
What is the primary use of this drug?
This drug temporarily relieves minor aches and pains of muscles and joints associated with strains, sprains, arthritis, and simple backache.
How often can I apply this drug?
Adults and children 2 years of age and older can apply it to the affected area no more than 3 to 4 times daily.
What should I do if I experience an allergic reaction?
Stop using the product and ask a physician if an allergic reaction occurs.
Are there any contraindications for this drug?
No specific contraindications are mentioned for this drug.
Can I use this drug near my eyes?
No, you should not use this drug in or near the eyes.
What should I do if I swallow this drug?
If swallowed, get medical help or contact a Poison Control Center immediately.
Is this drug safe for children under 2 years of age?
Consult a physician before using this drug on children under 2 years of age.
What should I do if my condition worsens or does not improve?
Stop using the product and consult a physician if your condition worsens or does not improve within 7 days.
How should I store this drug?
Store at room temperature and avoid excessive heat or cold.
Is there any information about using this drug during pregnancy or while nursing?
There is no specific information provided regarding use during pregnancy or nursing.
Packaging Info
Below are the non-prescription pack sizes of Painzone (external analgesic). 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
| ||||
| 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
| ||||
| 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 Painzone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.
Uses and Indications
This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joint conditions, including strains, sprains, arthritis, and simple backache. It provides penetrating pain relief to alleviate discomfort in these areas.
Dosage and Administration
For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.
For children under 2 years of age, it is advised to consult a physician prior to use to ensure safety and appropriateness of treatment.
Contraindications
The product is contraindicated for use in or near the eyes due to the potential for irritation or damage. Additionally, it should not be applied in large quantities, particularly over raw surfaces or blistered areas, to avoid exacerbating any underlying conditions or causing adverse effects. Care should be taken to prevent contact with the eyes during application.
Warnings and Precautions
For external use only. It is imperative that the product is not applied to the eyes, as contact may lead to irritation or other adverse effects.
Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances: if an allergic reaction occurs; if the condition being treated worsens or fails to improve within 7 days; if symptoms initially resolve but then return within a few days; or if any signs of redness, irritation, swelling, pain, or other symptoms develop or intensify.
In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.
Side Effects
Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be applied in or near the eyes.
In clinical practice, patients are advised to discontinue use and consult a physician if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after initial resolution, or the onset of redness, irritation, swelling, pain, or any other increasing symptoms.
Additionally, caution should be exercised to avoid using this product in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate adverse reactions.
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 Painzone (external analgesic). 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
| ||||
| 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
| ||||
| 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 under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.
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 PainZone external analgesic cream during pregnancy. Healthcare professionals should exercise caution when prescribing this medication to pregnant patients due to the lack of data on potential risks or fetal outcomes. It is recommended that women of childbearing potential discuss their pregnancy status and any potential risks with their healthcare provider before using this product.
Lactation
There are no specific warnings or recommendations regarding the use of PainZone external analgesic cream in lactating mothers. Additionally, there is no information available about the potential for excretion of the product in breast milk or any associated risks to breastfed infants.
Renal Impairment
Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.
Overdosage
In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the substance has been ingested.
Prompt intervention is crucial in managing potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and the substance's pharmacological profile.
Healthcare providers are encouraged to follow established protocols for the management of overdosage, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential to ensure safety and efficacy of the treatment provided.
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 for SPL code 90375-7.
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 not to use the product in or near the eyes, as this could lead to irritation or injury.
Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, to avoid potential adverse effects. They should be informed to discontinue use and consult a physician if they experience any signs of an allergic reaction.
Additionally, healthcare providers should emphasize that patients must stop using the product and seek medical advice if their condition worsens or does not improve within 7 days. Patients should also be instructed to stop use and consult a physician if symptoms resolve and then return within a few days. Furthermore, if patients notice any redness, irritation, swelling, pain, or other symptoms that begin or increase, they should be advised to stop using the product and seek medical attention.
Finally, while using the product, patients should be reminded to avoid contact with the eyes to prevent any complications.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat or cold to maintain its integrity and efficacy. Proper handling should be observed to prevent any potential degradation of the product.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Painzone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.