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Mederma Pm

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Active ingredient
Dimethicone 20 mg/1 mL
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 2020
Label revision date
March 14, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/1 mL
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 2020
Label revision date
March 14, 2024
Manufacturer
Merz North America
NDC root
46783-803
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

MEDERMA PM is a topical product designed to improve the appearance of scars. It is manufactured by Merz Pharma GmbH & Co. KGaA and comes in a 30 mL tube. This product is typically used to help reduce the visibility of scars, making them less noticeable over time.

Uses

It seems that there are no specific uses or indications provided for the medication in the information available. This means that the details about what the drug is used for, including any potential effects on pregnancy (teratogenic effects) or other non-pregnancy-related effects, are not specified.

If you have any questions about this medication or need information on a specific condition it may treat, it's best to consult with a healthcare professional who can provide you with the most accurate and relevant information.

Dosage and Administration

To use Mederma PM dimethicone cream, you will apply it directly to the skin. This cream contains 20 mg of dimethicone in every 1 mL, which helps to improve the appearance of your skin.

Make sure to apply the cream to the affected area as directed. Since this is a topical (applied to the skin) treatment, you can use it conveniently at home. Follow the recommended frequency for application to achieve the best results.

What to Avoid

You can feel reassured that there are no specific contraindications or "do not take" instructions associated with this medication. Additionally, it is not classified as a controlled substance, which means it does not carry the same risks of abuse or misuse that some other medications might. There are also no concerns regarding dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects while using this medication. Common reactions include allergic symptoms like rash, itching, and redness, as well as skin irritation and contact dermatitis. You might also notice difficulty breathing or wheezing, nausea, vomiting, headaches, dizziness, and palpitations (a feeling of rapid or irregular heartbeat).

In rare cases, severe allergic reactions, including anaphylaxis (a serious, life-threatening allergic reaction), have been reported. Additionally, some users have experienced skin blistering and peeling. It's also possible to feel a temporary stinging or burning sensation upon application. If you notice any of these effects, especially severe ones, please consult your healthcare provider.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided for this medication. This means there are no known risks or necessary precautions to be aware of while using it.

However, it's always a good practice to stay informed about any changes in your health or unusual symptoms. If you experience anything concerning, it's important to stop using the medication and consult your doctor for guidance. Always prioritize your health and well-being by keeping open communication with your healthcare provider.

Overdose

If you suspect an overdose, it’s important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help or contact your local poison control center.

While the specific details about overdose are not provided, it’s always best to err on the side of caution. If you think you or someone else may have taken too much of a medication, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

When considering the use of Mederma PM (dimethicone cream) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been studied or documented.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including topical creams like Mederma PM. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Mederma PM for nursing mothers. The information available does not indicate any concerns about the product being excreted in breast milk or affecting lactation.

As always, if you have any questions or concerns about using any product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

Mederma PM has not been tested for use in children, so its safety and effectiveness for pediatric patients (children and adolescents) are not known. As a parent or caregiver, it's important to be cautious and consult with a healthcare professional before using this product for your child. Always prioritize their safety and well-being by seeking guidance from a doctor regarding any treatments.

Geriatric Use

When considering the use of Mederma PM (dimethicone cream) for older adults, it's important to note that the drug insert does not provide specific information about how this product may affect elderly patients. This means there are no special dosage adjustments, safety concerns, or precautions outlined for older individuals.

As always, if you or a caregiver are considering using this product, it's a good idea to consult with a healthcare professional. They can provide personalized advice based on your health needs and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that the information provided for Mederma PM (dimethicone cream) does not include specific guidelines about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored recommendations for how this product may affect you if you have renal impairment.

Before using Mederma PM, it’s a good idea to consult with your healthcare provider to ensure it’s safe for you, especially since your kidney health may influence how your body processes medications and creams.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for Mederma PM (dimethicone cream) does not provide specific information about dosage adjustments, special monitoring, or precautions for patients with hepatic impairment (liver problems). This means that there are no established guidelines for how this product may affect you if you have liver issues.

Before using Mederma PM, it’s a good idea to consult with your healthcare provider to discuss your liver condition and any potential risks. They can help you determine the best course of action based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It's important to keep it away from light to maintain its effectiveness. When you're not using the product, make sure the tube is tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Mederma PM?

Mederma PM is a dimethicone cream manufactured by Merz Pharma GmbH & Co. KGaA, designed for topical application.

How should I use Mederma PM?

Apply Mederma PM dimethicone cream topically to the affected area as directed.

What are the active ingredients in Mederma PM?

The active ingredient in Mederma PM is dimethicone, with a concentration of 20 mg in 1 mL.

What are the possible side effects of Mederma PM?

Possible side effects include allergic reactions like rash and itching, skin irritation, difficulty breathing, nausea, headache, and palpitations.

Are there any contraindications for using Mederma PM?

There are no contraindications listed for Mederma PM.

Is Mederma PM safe for use during pregnancy?

There is no specific information regarding the safety of Mederma PM during pregnancy.

Can nursing mothers use Mederma PM?

There are no specific warnings or recommendations regarding the use of Mederma PM in nursing mothers.

What should I do if I experience severe allergic reactions?

In rare cases, severe allergic reactions, including anaphylaxis, may occur. Seek emergency medical help if you experience such symptoms.

How should I store Mederma PM?

Store Mederma PM at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the tube tightly closed when not in use.

Is Mederma PM suitable for pediatric use?

Pediatric use has not been established for Mederma PM, and safety and effectiveness in children have not been determined.

Packaging Info

Below are the non-prescription pack sizes of Mederma Pm (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mederma Pm.
Details

Drug Information (PDF)

This file contains official product information for Mederma Pm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

MEDERMA PM is identified by the National Drug Code (NDC) 46783-803-30. This product is available in a net volume of 30 mL. It is manufactured by Merz Pharma GmbH & Co. KGaA, located in Reinheim, Germany.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. The precise indications and usage details are not specified in the provided information.

Healthcare professionals are advised to consult relevant clinical data and guidelines to determine appropriate applications of this drug in practice. Further information regarding teratogenic and nonteratogenic effects is also not specified, and practitioners should exercise caution and refer to additional resources when considering this drug for patient treatment.

Dosage and Administration

Mederma PM dimethicone cream is intended for topical application. The active ingredient, dimethicone, is present at a concentration of 20 mg per 1 mL of cream.

Healthcare professionals should instruct patients to apply the cream directly to the affected area. The frequency of application should be determined based on individual patient needs and the severity of the condition being treated. It is essential to ensure that the area is clean and dry prior to application to maximize the effectiveness of the product.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any unexpected reactions or side effects during treatment.

As there are no recommended laboratory tests or specific instructions for emergency medical assistance or discontinuation of the medication, it is essential for healthcare providers to use their clinical judgment and experience when managing patient care. Regular follow-up and assessment of the patient's condition are encouraged to ensure safe and effective use of the medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of the product. Commonly reported reactions include allergic reactions such as hypersensitivity, which may manifest as rash, itching, and redness. Dermatologic reactions may also occur, including skin irritation and contact dermatitis.

Respiratory symptoms such as difficulty breathing and wheezing have been noted, alongside gastrointestinal disturbances including nausea and vomiting. Neurological effects may present as headache and dizziness, while cardiovascular reactions can include palpitations.

In clinical trials, participants reported transient stinging or burning sensations upon application, which were generally mild and self-limiting.

Postmarketing experience has revealed rare cases of severe allergic reactions, including anaphylaxis, as well as reports of skin blistering and peeling. These serious reactions underscore the importance of monitoring for any signs of hypersensitivity following administration.

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 Mederma Pm (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mederma Pm.
Details

Pediatric Use

Pediatric use of Mederma PM has not been established, and the safety and effectiveness in pediatric patients have not been determined. Therefore, caution should be exercised when considering this product for use in children, infants, or adolescents.

Geriatric Use

There is no specific information regarding the use of Mederma PM (dimethicone cream) in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise standard clinical judgment when considering the use of this product in the geriatric population. Monitoring for any adverse effects or unusual reactions is advisable, as with any patient group.

Pregnancy

There is no information available regarding the use of Mederma PM (dimethicone cream) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed before prescribing this product to pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of Mederma PM in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Mederma PM in breast milk or its effects on breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert for Mederma PM (dimethicone cream). Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Mederma PM (dimethicone cream). The prescribing information does not provide any recommendations regarding dosage adjustments, special monitoring, or precautions for individuals with compromised liver function. Therefore, healthcare professionals should exercise caution and consider the overall clinical context when prescribing this product to patients with hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on specific interventions and management strategies tailored to the individual case.

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 insert text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be cautioned to avoid contact with the eyes; in the event of contact, they should rinse the eyes thoroughly with water. It is important to inform patients not to apply the product to broken skin or open wounds.

Providers should emphasize the necessity of keeping the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to store the product at room temperature and to use it as directed to achieve the best results. Additionally, healthcare providers should counsel patients to discontinue use and consult a healthcare professional if any irritation occurs.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and must be protected from light exposure. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent contamination and ensure safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Mederma Pm, 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 Mederma Pm, 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

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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.