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Alcemiste

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
September 5, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
September 5, 2025
Manufacturer
Price Team Ventures, LLC
Registration number
M017
NDC root
87087-001
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 associated with various skin issues, including sunburns, minor cuts, insect bites, and other skin irritations. It works by soothing the affected area, helping you feel more comfortable while your skin heals. If you're dealing with any of these conditions, this product may help alleviate your discomfort.

Uses

If you're dealing with discomfort from sunburns, minor cuts, insect bites, or skin irritations, this medication can help. It provides temporary relief from pain and itching, allowing you to feel more comfortable while your skin heals.

You can use it to soothe those annoying symptoms and get back to enjoying your day. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer choice for many.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, simply apply it gently to the affected area. You can do this up to 3 to 4 times a day, depending on your needs.

However, if your child is under 2 years old, it's important to consult a healthcare professional before using this medication. They can provide guidance on whether it's safe and appropriate for your little one.

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 mentioned. This means that, based on the information provided, there are no particular restrictions or warnings about taking or using this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens or symptoms last more than seven days, or if symptoms improve and then return within a few days, it's important to stop using the product and consult a doctor. Additionally, avoid using it excessively, especially on raw or blistered skin, and do not apply it to wounds or damaged skin.

Keep this product out of reach of children. If swallowed, seek immediate medical attention or contact a Poison Control Center.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. If you notice that your condition worsens or if your symptoms last longer than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve but then return within a few days, it's important to reach out to your healthcare provider.

Be cautious not to use this product excessively, especially on raw or blistered skin, and do not apply it to wounds or damaged skin. Always keep it out of reach of children. If the product is swallowed, seek immediate medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Seek immediate medical attention or contact a Poison Control Center right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Remember, it’s always better to be safe and get help if you suspect an overdose. Don’t hesitate to reach out for assistance.

Pregnancy Use

The safety of lidocaine HCL cream during pregnancy has not been established, which means it’s important to be cautious. It is generally not recommended for use unless absolutely necessary. There may be potential risks to your fetus, so it’s crucial to consult with your healthcare professional before using this cream.

If you are pregnant, your doctor may suggest dosage adjustments to ensure safety. Always seek guidance from your healthcare provider to make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding and considering the use of lidocaine HCL cream, you can feel reassured that there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, the information available does not indicate any concerns about lidocaine being passed into breast milk or posing a risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

When using this medication for children aged 2 years and older, you can gently apply it to the affected area up to 3 to 4 times a day as needed. However, if your child is under 2 years old, it's important to consult a healthcare professional before using it.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek immediate medical attention or contact a Poison Control Center right away. Your child's safety is the top priority, so following these guidelines is essential.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. 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 related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep it protected from light, as exposure can affect its effectiveness. Please remember not to freeze the product, as this can damage it. Once you open the product, be sure to discard any unused portion to maintain safety and effectiveness.

Additional Information

For adults and children aged 2 years and older, you can gently apply the medication to the affected area up to 3 to 4 times a day as needed. If the patient is under 2 years old, it's important to consult a healthcare professional before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What conditions does this cream help relieve?

This cream provides temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and skin irritations.

How should I use this cream?

For adults and children aged 2 years and older, gently apply to the affected area up to 3 to 4 times daily as needed. For children under 2 years, consult a healthcare professional before use.

Are there any warnings I should be aware of?

Yes, this cream is for external use only. Avoid contact with the eyes, and stop use if the condition worsens or symptoms persist for more than 7 days.

What should I do if I accidentally swallow the cream?

If swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Is this cream safe to use during pregnancy?

The safety of this cream during pregnancy has not been established, and it is not recommended unless clearly needed. Consult a healthcare professional for guidance.

Can I use this cream while breastfeeding?

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

How should I store this cream?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Alcemiste.
Details

Drug Information (PDF)

This file contains official product information for Alcemiste, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and various skin irritations.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the medication should be gently applied to the affected area. The application may be performed up to 3 to 4 times daily as needed, depending on the severity of the condition.

In children under 2 years of age, the use of this medication is not recommended without prior consultation with a healthcare professional.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. In the event that the condition worsens or symptoms persist for more than 7 days, the patient should discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

Excessive use of this product should be avoided, particularly on raw or blistered skin. The recommended daily dosage should not be exceeded unless specifically directed by a healthcare provider. This product must not be applied to wounds or damaged skin.

To ensure safety, this product should be kept out of reach of children. In the case of accidental ingestion, immediate medical attention 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. In the event that the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, medical consultation is recommended.

Excessive use of the product, particularly on raw or blistered skin, should be avoided. Patients should not exceed the recommended daily dosage unless specifically advised by a healthcare professional. The product is contraindicated for use on wounds or damaged skin.

It is crucial to keep the product out of reach of children. In the case of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Alcemiste (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alcemiste.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by gently applying it to the affected area up to 3 to 4 times daily as needed. For children under 2 years of age, the product should not be used without prior consultation with a healthcare professional.

It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

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, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine HCL cream during pregnancy has not been established. The use of this medication is not recommended during pregnancy unless clearly needed, as there may be potential risks to the fetus. Healthcare professionals should be consulted prior to use to evaluate the necessity and potential risks associated with lidocaine HCL cream in pregnant patients.

Dosage adjustments may be necessary for individuals who are pregnant. It is essential for healthcare providers to assess and provide guidance on appropriate dosing to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine HCL cream in lactating mothers. Additionally, the insert does not provide statements concerning the potential for excretion of lidocaine in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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, it is imperative that immediate medical attention is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; however, it is crucial to monitor the patient closely for any signs of adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and improve patient outcomes.

Management of overdosage should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Healthcare providers are encouraged to follow established protocols for the assessment and treatment of overdosage cases, which may include supportive care and symptomatic treatment as necessary.

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 to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity. It is essential to protect the product from light exposure to prevent degradation. Freezing is not permitted, as it may compromise the quality of the product. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

For adults and children aged 2 years and older, the product should be gently applied to the affected area up to 3 to 4 times daily as needed. For children under 2 years, it is advised not to use the product without consulting a healthcare professional.

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 Alcemiste, 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 Alcemiste, 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.