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Penichillin

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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)
Marketed in the U.S.
Since 2023
Label revision date
August 17, 2023
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
Marketed in the U.S.
Since 2023
Label revision date
August 17, 2023
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
part348
NDC root
54723-012

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If you are a consumer or patient please visit this version.

Drug Overview

You can use this medication for temporary relief of pain and itching caused by minor skin irritation. It is designed to help soothe discomfort, allowing you to feel more comfortable while your skin heals. If you have any specific questions about how it works or its uses, feel free to ask your healthcare provider for more information.

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, making it a safer option for those concerned about such risks.

Dosage and Administration

You can use this medication for treating affected areas on your skin. If you are an adult or a child who is two years or older, apply it to the affected area no more than three to four times a day. Make sure to apply it gently in a circular motion for about 30 to 60 seconds to help it absorb properly.

If your child is under two years old, it's important to consult a physician (doctor) before using this medication. They can provide guidance on the best approach for your child's specific needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of some warnings associated with this product. It is meant for external use only, so you should avoid getting it in your eyes. Additionally, you should not use it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult your doctor.

Make sure to keep this product out of reach of children. If it is accidentally swallowed, seek medical help or contact a poison control center right away.

Warnings and Precautions

This product is intended for external use only, so be sure to avoid contact with your eyes. It's important not to apply it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Always keep this product out of reach of children. If it is accidentally swallowed, seek medical help or contact a poison control center right away.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical help right away or contact a poison control center. Acting quickly can make a significant difference in ensuring safety and proper care.

Signs of an overdose may include unusual symptoms, so it's crucial to be aware of any changes in behavior or health. If you notice anything concerning, don’t hesitate to get help immediately. Your health and safety are the top priority.

Pregnancy Use

There is currently no specific information available regarding the use of PENICILLIN-benzocaine cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this cream. They can provide guidance based on your individual health needs and circumstances.

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 are no statements about the product being present in breast milk or any associated risks for your infant. This means you can use the product without concern for its effects on your milk production or your baby's health.

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 to four times a day. For children under two years old, it's important to consult a physician (doctor) before use. If you do use it on younger children, make sure to apply it in a circular motion for 30 to 60 seconds to ensure proper coverage. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

While there is no specific information about the use of PENICILLIN-benzocaine cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

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 monitor your kidney health and make any necessary adjustments to your medications.

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 great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all your current medications and any lab tests you may be undergoing with your healthcare provider. This ensures that you receive the safest and most effective care tailored to your needs. Always keep your healthcare team informed about any changes in your health or medication regimen.

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

For adults and children aged two years and older, you should apply the medication to the affected area no more than 3 or 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use. When applying, do so in a circular motion for 30 to 60 seconds to ensure proper coverage.

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.

Who can use this drug?

Adults and children two years or older can use this drug. For children under 2 years of age, you should consult a physician.

How should I apply this drug?

Apply to the affected area not more than 3 or 4 times daily. For children under 2, apply in a circular motion for 30 to 60 seconds.

Are there any warnings I should be aware of?

Yes, this product is 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?

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

What should I do if the product is swallowed?

If the product is swallowed, get medical help or contact a poison control center immediately.

Is there any information regarding use during pregnancy or lactation?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do to store this product?

Protect this product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Penichillin.
Details

Drug Information (PDF)

This file contains official product information for Penichillin, 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 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 reported for 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 optimal results, the product should be applied in a circular motion for a duration of 30 to 60 seconds.

In the case of children under two years of age, it is advised to consult a physician prior to use.

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 over raw surfaces or blistered areas, to prevent potential adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

This product must be kept 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.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas.

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

The product should be kept out of reach of children. In cases where the product is swallowed, it is imperative to seek medical assistance or contact a poison control center immediately.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Penichillin.
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. When applying the medication, it should be administered in a circular motion for 30 to 60 seconds to ensure proper application.

Geriatric Use

There is no specific information regarding the use of PENICILLIN-benzocaine cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for this population.

Pregnancy

There is no specific information regarding the use of PENICILLIN-benzocaine cream in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when treating pregnant patients with this product.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management of overdosage should be guided by the severity of symptoms and may include supportive care and symptomatic treatment as necessary. It is imperative that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

For adults and children aged two years or older, the medication should be applied to the affected area no more than 3 or 4 times daily. For children under the age of 2, it is advised to consult a physician before use. When applying, clinicians should instruct patients to use a circular motion for 30 to 60 seconds.

Drug Information (PDF)

This file contains official product information for Penichillin, 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 Penichillin, 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.