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Black Label

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Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
Other brand names
Dosage form
Spray
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
February 22, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
Other brand names
Dosage form
Spray
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
February 22, 2024
Manufacturer
SCALP TECH INC
Registration number
M015
NDC root
82617-103
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

You may find that this medication is designed to temporarily relieve symptoms associated with hemorrhoids, also known as piles. These symptoms include itching, pain, soreness, and burning sensations in the affected area.

By targeting these discomforts, the medication aims to provide you with some relief, allowing you to manage the symptoms more effectively. If you're experiencing these issues, this treatment could be a helpful option to consider.

Uses

If you're dealing with discomfort from hemorrhoids, hemorrhoidal tissues, or piles, this medication can help. It temporarily relieves symptoms such as itching, pain, soreness, and burning, making it easier for you to go about your day without the nagging discomfort.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

To use this product effectively, start by cleansing the affected area with mild soap and warm water. Make sure to rinse it well or gently pat it dry using an appropriate cleansing pad. After that, dry the area by patting or blotting it with toilet tissue or a soft cloth.

Once the area is clean and dry, you can apply the product using the spray pump. You should apply it externally to the affected area up to four times a day, but be careful not to use it more often than directed. Following these steps will help ensure you get the best results from the treatment.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, please call a poison control center or seek medical help immediately.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if you experience any bleeding, if your condition worsens or does not improve within 7 days, or if you notice redness, irritation, swelling, or pain. Additionally, seek medical attention if you feel weak, confused, have a headache, difficulty breathing, or notice your skin turning pale, grey, or blue. These symptoms could indicate a rare condition called methemoglobinemia, which may develop within 2 hours after use.

Before using this product, it's advisable to talk to a doctor or pharmacist if you have any of the following: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating, or if you take medication for high blood pressure or have a history of depression. Remember, this product is for external use only, and you should not insert it into the rectum using fingers or any devices.

Warnings and Precautions

This product is for external use only. Before using it, please consult with your doctor or pharmacist if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating, or if you take medication for high blood pressure or have depression. It's important to avoid inserting the product into the rectum using fingers or any mechanical device.

You should stop using this product and call your doctor if you experience any bleeding, if your condition worsens or does not improve within 7 days, or if you notice redness, irritation, swelling, pain, or other concerning symptoms. Additionally, seek medical attention if you feel weak, confused, have a headache, difficulty breathing, or notice your skin turning pale, grey, or blue, as these could be signs of a rare disorder called methemoglobinemia, which may develop up to 2 hours after use.

Keep this product out of reach of children. If swallowed, it’s crucial to call a poison control center or seek medical help immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride spray during pregnancy has not been established. This product is generally not recommended for use while pregnant due to potential risks to your developing baby. If you are considering using this spray, please consult your healthcare provider to discuss any possible risks and to receive personalized advice.

Additionally, if you do use this product, your healthcare provider may suggest dosage adjustments tailored to your specific situation. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your baby.

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

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should call a poison control center or seek medical help immediately.

This medication is intended for use in adults and children aged 12 years and older. Always follow the directions carefully to ensure safety and effectiveness.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 for patients with 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15° and 30°C (59° to 86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply the spray pump to the affected area up to four times a day, but make sure not to use it more often than directed. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves symptoms due to hemorrhoids, including itching, pain, soreness, and burning.

How should I apply this product?

Cleanse the affected area with mild soap and warm water, rinse well, and gently dry before applying the spray pump externally to the affected area up to 4 times daily.

Are there any contraindications for using this product during pregnancy?

Yes, the use of this product is contraindicated in pregnancy due to potential risks to the fetus. Consult your healthcare provider for advice.

What should I do if I experience severe side effects?

Stop using the product and call your doctor if you experience bleeding, worsening symptoms, or signs of methemoglobinemia, such as weakness or difficulty breathing.

Is this product safe for nursing mothers?

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

What should I do if the product is swallowed?

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

What precautions should I take before using this product?

Ask a doctor or pharmacist before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination.

How should I store this product?

Store at room temperature between 15° - 30°C.

Packaging Info

Below are the non-prescription pack sizes of Black Label (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Black Label.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hemorrhoids, hemorrhoidal tissues, or piles. These symptoms include itching, pain, soreness, and burning.

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

Dosage and Administration

The affected area should be cleansed with mild soap and warm water prior to application. After cleansing, it is essential to rinse well or pat the area dry using an appropriate cleansing pad. The area must then be gently dried by patting or blotting with toilet tissue or a soft cloth before the application of the product.

For adults and children aged 12 years and over, the product should be applied externally to the affected area using the spray pump. The recommended frequency of application is up to four times daily. It is important to adhere to this frequency and not to exceed the directed usage.

Contraindications

Use of this product is contraindicated in situations where it may be accessible to children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a poison control center or obtaining medical help.

Warnings and Precautions

FOR EXTERNAL USE ONLY. Healthcare professionals should advise patients to consult a doctor or pharmacist prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination, are taking medication for high blood pressure, or have a history of depression.

During the use of this product, it is imperative that patients do not insert it into the rectum using fingers, mechanical devices, or applicators, as this may lead to adverse effects.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: bleeding, worsening of the condition, or lack of improvement within 7 days. Additionally, if patients experience redness, irritation, swelling, pain, or any of the following symptoms—weakness, confusion, headache, difficulty breathing, or pale, grey, or blue-colored skin—they should seek medical attention immediately. These symptoms may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after application.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should be advised to contact a poison control center or seek emergency medical assistance without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Prior to use, it is advisable for patients to consult a doctor or pharmacist if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination, are taking medication for high blood pressure, or have a history of depression.

During the use of this product, patients must avoid inserting it into the rectum using fingers, mechanical devices, or applicators.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: bleeding, worsening of the condition, or lack of improvement within 7 days. Additionally, if symptoms such as redness, irritation, swelling, pain, weakness, confusion, headache, difficulty breathing, or changes in skin color (pale, grey, or blue) arise, medical consultation is necessary. These symptoms may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after application.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Black Label (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Black Label.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, it is imperative to contact a poison control center or seek medical assistance immediately.

The medication is indicated for use in adults and children aged 12 years and older. There are no specified dosage adjustments or efficacy data provided for younger pediatric populations. Therefore, caution is advised when considering this medication for individuals under 12 years of age.

Geriatric Use

There is no specific information 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 lidocaine hydrochloride spray during pregnancy has not been established. The use of this product is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women are advised to discuss the use of this product with their healthcare provider before use to ensure the safety and well-being of both the mother and the fetus.

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 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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

During postmarketing experience, the following adverse reactions have been reported: methemoglobinemia, a rare disorder that may manifest up to 2 hours after use. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should immediately call a poison control center or seek medical assistance. It is essential for patients to understand the urgency of the situation and the importance of prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C. Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the medication using a spray pump to the affected area, with a maximum frequency of up to four times daily. It is important for patients to adhere to the recommended usage and not exceed the directed application frequency. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Black Label, 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 Black Label, 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.