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Doloran
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This product has been discontinued
- Active ingredients
- Camphor, (-) - 0.08 g/1 g
- Menthol 0.08 g/1 g
- Methyl Salicylate 0.02 g/1 g
- Other brand names
- Dosage form
- Ointment
- 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
- December 27, 2019
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Camphor, (-) - 0.08 g/1 g
- Menthol 0.08 g/1 g
- Methyl Salicylate 0.02 g/1 g
- Other brand names
- Dosage form
- Ointment
- 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
- December 27, 2019
- Manufacturer
- Hector Rivera Garzon y Compania. S. en C.
- Registration number
- part348
- NDC root
- 71016-001
- 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 aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this drug may provide the relief you need.
Uses
You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your comfort.
Rest assured, there are no known 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 best to consult a doctor before use. This will help ensure that the medication 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 to prevent accidental ingestion. If a child swallows it, seek medical help or contact a Poison Control Center right away. Always prioritize safety and ensure that this medication is stored securely.
Side Effects
When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid applying it to wounds or damaged skin. If you have a child under 12 years old with arthritis-like conditions, do not use this product on them. Be careful to keep it away from your eyes, and if your condition worsens or symptoms last more than 7 days, or if they improve and then return shortly after, stop using the product and consult a doctor. Additionally, avoid tightly bandaging the area where you apply it.
Warnings and Precautions
This product is for external use only, so please avoid applying it to wounds or damaged skin. If you are considering using it on a child under 12 years old who has arthritis-like conditions, it's best to consult a doctor first. Be careful to keep the product away from your eyes, and do not bandage the area tightly after application.
If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, stop using the product and reach out to your doctor. Always keep this product out of reach of children to prevent accidental ingestion. If swallowed, seek 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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, 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
When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.
As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that the ingredients could pass into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help ensure the safety and well-being of both you and your baby.
Pediatric Use
If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age who have arthritis-like conditions. For any child under 12, it's best to consult with a doctor before use to ensure safety and appropriateness. Always prioritize your child's health by seeking professional guidance when it comes to medications.
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. 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.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any changes you may need to make regarding your treatment or how your kidney health might affect the medication.
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 you understand how to manage your health while considering your kidney function.
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. 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 best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.
Additional Information
You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. 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 related to this medication.
FAQ
What conditions does this drug temporarily relieve?
This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Who can use this drug?
Adults and children 12 years of age and older can use this drug. For children under 12 years, you should ask a doctor.
How often can I apply this drug?
You can apply this drug to the affected area not more than 3 to 4 times daily.
Are there any warnings I should be aware of?
Yes, this drug is for external use only. Avoid using it on wounds or damaged skin, and do not apply it to children under 12 years of age with arthritis-like conditions.
What should I do if I accidentally swallow this drug?
If swallowed, you should get medical help or contact a Poison Control Center immediately.
Is this drug safe to use during pregnancy?
There is no specific information regarding the use of this drug during pregnancy, and it is not contraindicated. However, you should consult a doctor.
Can nursing mothers use this drug?
Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.
How should I store this drug?
Store the drug at room temperature, protect it from light, and keep the container tightly closed. Discard it after opening.
Packaging Info
Below are the non-prescription pack sizes of Doloran (menthol, camphor, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment |
| ||
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 Doloran, 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 aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.
Contraindications
Use of this product is contraindicated in situations where accidental ingestion by children may occur. To prevent potential harm, it is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.
Warnings and Precautions
This product is intended for external use only and should not be applied to wounds or damaged skin, including areas with a healing pad. It is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.
Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is imperative to discontinue use and seek medical consultation.
Additionally, the product should not be bandaged tightly, as this may exacerbate potential adverse effects. It is crucial to keep this product out of reach of children to prevent accidental ingestion. In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
Side Effects
Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should not be applied to wounds or damaged skin, particularly in the presence of a healing pad. Additionally, the product is contraindicated for use in children under 12 years of age who have arthritis-like conditions. Care should be taken to avoid contact with the eyes.
In clinical practice, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional. Furthermore, patients should avoid applying the product to wounds or damaged skin and should not bandage the area tightly.
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 Doloran (menthol, camphor, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment |
| ||
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 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.
Geriatric Use
There is no specific information available 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 should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.
Lactation
Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.
Renal Impairment
There is no specific information available 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 advisable in this patient population.
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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent, provided there are no contraindications.
Further management should be guided by the clinical scenario and may involve specific antidotes or interventions as indicated. Consultation with a poison control center or toxicology expert is recommended for tailored management strategies.
Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing care and treatment decisions.
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 understanding of the compound's potential effects in these areas.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with ingestion by children.
In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This prompt action is crucial for ensuring the safety and well-being of the patient.
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. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded 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 of age, it is advised to consult a doctor regarding the application. There is no additional information available concerning laboratory tests, abuse potential, patient counseling, or postmarketing experiences.
Drug Information (PDF)
This file contains official product information for Doloran, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.