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Inderma Md

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 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 2023
Label revision date
April 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 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 2023
Label revision date
April 6, 2023
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
part348
NDC root
54723-009
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 provide temporary relief from pain and itching caused by minor skin irritations. It can be helpful if you're dealing with discomfort from conditions like insect bites, minor cuts, or rashes. While the specific mechanism of action isn't detailed, its primary purpose is to soothe your skin and alleviate discomfort.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. It’s designed to help soothe discomfort and make your skin feel better.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

You can use this medication for yourself or your child if they are two years or older. Simply apply it to the affected area, but make sure to do this no more than three or four times a day. If your child is under two years old, it's important to consult a physician (doctor) before using the medication.

When applying, use a circular motion for about 30 to 60 seconds. This helps ensure that the medication is evenly distributed and absorbed into the skin. Remember to follow these guidelines for the best results!

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where your body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your situation.

Side Effects

It's important to be aware of some warnings when using this product. It is meant for external use only, so you should avoid getting it in your eyes. Additionally, you should not apply it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if your symptoms last more than seven days or improve and then return within a few days, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last longer than 7 days or come back after improving, stop using the product and consult your doctor.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately. It's important to prioritize your safety and well-being while using this medication.

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 feel unwell after taking the medication, 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 after taking medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is generally not recommended during pregnancy. If you are considering using this medication, it’s crucial to consult your healthcare provider for personalized advice.

Additionally, there are no specific dosage modifications for pregnant individuals, so any use should be under the guidance of a physician. To ensure the safety of both you and your baby, avoid using benzocaine unless directed by a healthcare professional.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than three or four times a day. However, if your child is under two years old, it’s important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

Geriatric Use

When considering the use of INDERMA MD - benzocaine cream for older adults, it's important to note that the drug insert does not provide specific information about how this medication should be adjusted or used differently in elderly patients. This means there are no special dosage changes or safety precautions outlined for older adults.

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

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You should apply this medication topically to the affected area, using a circular motion for 30 to 60 seconds. For adults and children aged two years and older, you can use it up to 3 or 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching due to minor skin irritation.

How should I apply this drug?

For adults and children two years or older, apply to the affected area not more than 3 or 4 times daily, using a circular motion for 30 to 60 seconds.

Is this drug safe for children under 2 years?

For children under 2 years of age, you should consult a physician before use.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but benzocaine is contraindicated in pregnancy due to potential risks to the fetus.

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 while using this drug?

Use this drug for external use only, avoid contact with eyes, and do not use in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

The safety of benzocaine during pregnancy has not been established, and it should be avoided unless directed by a healthcare professional.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Protect this product from excessive heat and direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Inderma Md (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inderma Md.
Details

Drug Information (PDF)

This file contains official product information for Inderma Md, 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 additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

When applying the medication, it should be administered in a circular motion for a duration of 30 to 60 seconds to ensure proper absorption and effectiveness.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the user should discontinue use and consult a healthcare professional.

Emergency medical assistance should be sought immediately if the product is swallowed. In such cases, contacting a Poison Control Center is strongly advised.

Users are reminded to stop taking the product and consult their doctor under the aforementioned circumstances, ensuring that any potential complications are addressed promptly.

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to avoid contact with the eyes to prevent irritation or injury. The use of large quantities, especially over raw surfaces or blistered areas, is not recommended due to the potential for adverse effects.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. 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 Inderma Md (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inderma Md.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is recommended to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for INDERMA MD - benzocaine cream. As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any adverse effects or unusual responses to treatment, given the general considerations for increased sensitivity to medications in this age group.

Pregnancy

The safety of benzocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks with the use of benzocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage modifications for pregnant individuals have not been specified, and healthcare professionals should be consulted for guidance regarding the use of benzocaine in this population. Pregnant women are advised to avoid using benzocaine unless directed by a healthcare professional, ensuring that any potential risks to fetal outcomes are carefully considered.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 advisable 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 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged two years or older. For children under two years of age, consultation with a physician is advised. Application should be performed in a circular motion for a duration of 30 to 60 seconds.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Inderma Md, 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 Inderma Md, 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.