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Petrocort Antipruritic Lip 21

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Active ingredient
Hydrocortisone 0.005 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lipstick
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 15, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.005 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lipstick
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 2017
Label revision date
December 15, 2023
Manufacturer
Clinical Formula LLC
Registration number
M017
NDC root
51822-021
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 minor skin irritations and rashes. It is particularly helpful for preventing and protecting chafed, chapped, cracked, windburned, or sunburned lips. Suitable for both adults and children aged 5 years and older, it offers a soothing solution for various skin discomforts.

Uses

You can use this product for the temporary relief of minor skin irritations and rashes for both adults and children aged 5 years and older. It also helps to prevent and temporarily protect your lips from becoming chafed, chapped, cracked, or damaged by windburn or sunburn.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe option for many users.

Dosage and Administration

You can apply this medication to your lips one to three times a day, or as your doctor advises. If you are considering using it for a child under the age of five, it's important to consult with a physician first to ensure it's safe and appropriate for them. Always follow the guidance provided by your healthcare provider for the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

When using this medication, it's important to remember that it is for external use only. If your condition worsens, does not improve, or if symptoms persist for more than 7 days, or clear up and then come back within a few days, you should stop using it and consult a physician. Additionally, be sure to keep the product away from heat to ensure its effectiveness.

Warnings and Precautions

This product is intended for external use only. If your condition worsens, does not improve, or if symptoms last longer than 7 days, or if they clear up and then come back within a few days, you should stop using it and consult your doctor. It's also important to keep the product away from heat and out of reach of children to ensure safety.

If you experience any unexpected reactions or side effects, seek emergency help immediately. Always prioritize your health and well-being by following these guidelines closely.

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.

Pregnancy Use

When it comes to using Petrocort Antipruritic Lip Balm during pregnancy, there is currently no specific information available about its safety or any necessary precautions. This means that the insert does not address whether it is safe to use during this time, how much you should use, or if there are any special considerations to keep in mind.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this product. They can provide personalized advice and help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If your child is 5 years old or older, this medication can be used to temporarily relieve minor skin irritations and rashes. However, if your child is under 5 years of age, it’s important to consult a physician (doctor) before using this product. This ensures that you receive the best advice for your child's specific needs and safety. 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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver 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 standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver issues.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

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 and safety of your product, it’s important to store it properly. Keep the product away from heat sources and store it at room temperature. This helps maintain its effectiveness and prevents any potential damage.

When handling the product, always do so with care to avoid any contamination or damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication to your lips 1 to 3 times daily, or use it as directed by your physician. If you have any questions about how to use it or need further guidance, don't hesitate to reach out to your healthcare provider.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of minor skin irritations and rashes, and to help prevent and protect chafed, chapped, cracked, windburned, or sunburned lips.

Who can use this drug?

It is applicable to adults and children 5 years and over. For children under 5 years of age, you should consult a physician.

How often should I apply this drug?

You should apply it to your lips 1-3 times daily or use as directed by your physician.

Are there any warnings I should be aware of?

Yes, this drug is for external use only. If your condition worsens, does not improve, or symptoms persist for more than 7 days, you should discontinue use and consult a physician.

Is there any information regarding its use during pregnancy or lactation?

The insert does not provide specific information regarding the use of this drug during pregnancy or lactation.

What should I do if I keep this drug?

You should keep it from heat and store it at room temperature, out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Petrocort Antipruritic Lip 21 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Petrocort Antipruritic Lip 21.
Details

Drug Information (PDF)

This file contains official product information for Petrocort Antipruritic Lip 21, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations and rashes in adults and children aged 5 years and older. It also serves to help prevent and temporarily protect chafed, chapped, cracked, windburned, or sunburned lips.

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

Dosage and Administration

The product should be applied to the lips 1 to 3 times daily, or as directed by a physician. For pediatric patients under 5 years of age, it is recommended to consult a physician prior to use.

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

For external use only. It is imperative that healthcare professionals advise patients to discontinue use and consult a physician if the condition worsens, does not improve, or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then reoccur within a few days, medical consultation is recommended.

The product should be stored away from heat sources to maintain its efficacy.

Healthcare professionals must also emphasize the importance of keeping this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the product is intended for external use only. In the event that the condition worsens, does not improve, or symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, it is advised to discontinue use and consult a physician. Additionally, the product should be kept away from heat to ensure safety and efficacy.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Petrocort Antipruritic Lip 21 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Petrocort Antipruritic Lip 21.
Details

Pediatric Use

Pediatric patients aged 5 years and older may use this medication for the temporary relief of minor skin irritations and rashes. For children under 5 years of age, it is advised to consult a physician prior to 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of Petrocort Antipruritic Lip Balm during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals are advised to exercise caution when recommending this product to pregnant patients. There are no available studies or risk categories that delineate potential fetal impacts or necessary dosage modifications for pregnant women. It is recommended that women of childbearing potential discuss their individual circumstances with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It is essential to keep the product away from heat sources to maintain its efficacy. The recommended storage condition is at room temperature, ensuring that the product remains stable and effective for its intended use. Proper handling should be observed to prevent exposure to extreme temperatures.

Additional Clinical Information

Patients are advised to apply the product to the lips 1-3 times daily, or as directed by their physician. 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 Petrocort Antipruritic Lip 21, 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 Petrocort Antipruritic Lip 21, 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.

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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.