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Cutiecaine

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
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 2010
Label revision date
May 31, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
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 2010
Label revision date
May 31, 2010
Manufacturer
Innovatech Inc
Registration number
part348
NDC root
50876-111
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

I'm sorry, but it seems that the information provided does not include any relevant details about the drug itself, such as its name, uses, or mechanism of action. Without these key facts, I cannot create a summary that describes what the drug is or what it is used for. If you have more specific information about the drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific indications or usage details provided for this medication. This means that the information about what this drug is used for is currently unavailable. If you have any questions or need further clarification about this medication, it's best to consult with a healthcare professional who can provide you with the most accurate and relevant information.

Dosage and Administration

If you're looking to relieve pain or discomfort from minor cuts, abrasions, burns (including sunburn), insect bites, poison ivy, hemorrhoids, or itching, this medication can help. To use it, apply a small amount—about 1 to 2 grams—directly onto the affected area of your skin. Gently massage it in to help numb the skin or alleviate pain. It's important not to cover the area after applying the medication, as this can interfere with its effectiveness.

If you have a child under the age of 2, it's best to consult your doctor before using this medication to ensure it's safe for them. Always follow these guidelines to get the most benefit from your treatment.

What to Avoid

It's important to use this medication safely to avoid potential harm. You should never apply it in or near your eyes, as this can cause serious irritation or damage. Additionally, avoid using large amounts, especially on raw surfaces or blisters, as this can lead to adverse effects.

To ensure your safety, strictly follow these guidelines: do not use the medication in or around your eyes, and refrain from applying it in excessive quantities on sensitive areas like raw skin or blisters. Taking these precautions will help you use the medication effectively while minimizing risks.

Side Effects

You may experience some side effects when using Cutiecaine, a topical lidocaine cream. Common reactions include itching, redness, burning, and swelling of the skin. Allergic reactions can also occur, so it's important to be aware of any unusual symptoms. If you notice that your condition worsens or does not improve, or if symptoms clear up and then return within a few days, stop using the cream and consult your doctor.

Please remember not to apply the cream near your eyes or in large amounts, especially on raw surfaces or blisters.

Warnings and Precautions

You should avoid using this medication in or near your eyes, and be cautious not to apply it in large amounts, especially on raw surfaces or blisters. It's important to keep both used and unused medicine out of reach of children and pets. If the medication is swallowed, seek medical attention immediately.

If you experience any allergic reactions, notice that your condition worsens or does not improve, or if symptoms clear up and then return within a few days, stop using the medication and contact your doctor. Additionally, if you experience itching, redness, burning, swelling, or any other concerning symptoms, reach out to your healthcare provider for guidance.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. Call your doctor right away to discuss the situation.

Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell after taking the medication, don’t hesitate to reach out for assistance. Prompt action can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of Cutiecaine (topical lidocaine cream) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how it may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical treatments like Cutiecaine. They can help you weigh the potential benefits and risks based on your individual circumstances.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

If your child is under 2 years old, it's important to consult your doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize professional guidance when it comes to the health of young children.

Geriatric Use

While there is no specific information about the use of Cutiecaine (topical lidocaine 4% w/w cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this medication. They can provide guidance tailored to your individual health needs and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for Cutiecaine (topical lidocaine cream) does not provide specific information about dosage adjustments or special monitoring for patients like you. This means that there are no established guidelines regarding how to use this medication safely if you have renal impairment (kidney issues).

Always consult your healthcare provider before using any medication, especially if you have kidney concerns, to ensure it is safe and appropriate for your situation. Your doctor can provide personalized advice based on your health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for Cutiecaine (topical lidocaine cream) does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have liver impairment.

Before using Cutiecaine, it’s a good idea to discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety while using this medication.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to ensure the best care for your health.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and keep it protected from light. It's important to keep both used and unused medicine out of the reach of children and pets to prevent accidental ingestion. Once you open the product, remember to discard it after use to maintain safety and hygiene.

Additional Information

You should apply this medication topically, meaning it is meant to be applied directly to the skin. It's important to avoid using it near your eyes and to refrain from applying large amounts, especially on raw surfaces or blisters. If you experience any allergic reactions, worsening of your condition, or if symptoms return after improvement, you should stop using the product and consult your doctor. Additionally, if you notice any itching, redness, burning, or swelling, seek medical advice.

Always keep both used and unused medicine out of reach of children and pets. If the medication is swallowed, seek medical attention immediately by calling your doctor.

FAQ

What is the recommended amount to use?

You should use a small amount of 1 to 2 grams of this medication.

How should I apply the medication?

Apply it on the skin with a gentle massage to numb the skin or relieve pain, but do not occlude the area.

Are there any age restrictions for use?

For children under 2 years of age, you should consult your doctor before use.

What should I avoid when using this medication?

Do not use it in or near the eyes, and avoid using large amounts, especially over raw surfaces or blisters.

What are the possible side effects?

Possible side effects include allergic reactions, itching, redness, burning, and swelling.

What should I do if I experience side effects?

Stop use and ask your doctor if you experience allergic reactions or if your condition worsens and does not improve.

How should I store this medication?

Store it at room temperature, protect it from light, and keep it out of the reach of children or pets.

What should I do if the medication is swallowed?

If swallowed, get medical attention right away and call your doctor immediately.

Packaging Info

Below are the non-prescription pack sizes of Cutiecaine (topical lidocaine (4% w/w)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cutiecaine.
Details

Drug Information (PDF)

This file contains official product information for Cutiecaine, 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 SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is supplied in bottles containing 100 tablets.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.

Healthcare professionals are advised to consider the absence of teratogenic and nonteratogenic effects when evaluating the drug for patient treatment. Further information regarding specific indications may be obtained from clinical studies or additional resources as they become available.

Dosage and Administration

This medication is indicated for the reduction of pain or discomfort associated with minor cuts, abrasions, minor burns, sunburns, insect bites, poison ivy, hemorrhoidal pain, and itching.

For application, a small amount of 1 to 2 grams should be used. The medication should be applied topically to the affected area of the skin with a gentle massage to facilitate numbing and pain relief. It is important to avoid occlusion of the area after application.

For pediatric patients under the age of 2 years, it is recommended that healthcare professionals consult with a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied in or near the eyes due to the potential for irritation or damage to ocular tissues. Additionally, it is contraindicated to use large amounts of the product, particularly over raw surfaces or blisters, as this may exacerbate irritation or lead to adverse effects.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings This medication must not be applied in or near the eyes. Additionally, it should not be used in large amounts, particularly on raw surfaces or blisters, as this may lead to adverse effects.

General Precautions Both used and unused medication should be stored out of the reach of children and pets to prevent accidental ingestion. In the event of accidental swallowing, immediate medical attention is required.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare professional if any of the following occur:

  • Signs of allergic reactions.

  • Worsening of the condition or lack of improvement.

  • Symptoms that initially resolve but return within a few days.

  • The presence of itching, redness, burning, swelling, or any other concerning symptoms.

Get Emergency Medical Help Instructions In cases of accidental ingestion, it is crucial to contact a healthcare provider immediately for further guidance and intervention.

Side Effects

Patients using Cutiecaine, a topical lidocaine (4% w/w) cream, may experience a range of adverse reactions. Allergic reactions have been reported, which may manifest in various forms.

Common skin reactions include itching, redness, burning, and swelling. Additional symptoms may also occur, although they are not specifically enumerated.

It is important to note specific warnings associated with the use of this product. Cutiecaine should not be applied in or near the eyes, and caution is advised against using large amounts, particularly over raw surfaces or blisters.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens or does not improve, or if symptoms resolve and then return within a few days.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cutiecaine (topical lidocaine (4% w/w)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cutiecaine.
Details

Pediatric Use

Pediatric patients under 2 years of age should be evaluated by a healthcare professional prior to use. It is essential to consider the specific needs and potential risks associated with this age group.

Geriatric Use

There is no specific information regarding the use of Cutiecaine (topical lidocaine 4% w/w cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic responses compared to younger individuals.

Pregnancy

There are no specific statements regarding the use of Cutiecaine (topical lidocaine cream) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks and benefits of using this medication in pregnant patients should be carefully considered. Healthcare professionals are advised to evaluate the necessity of treatment with Cutiecaine in women of childbearing potential and to discuss any potential risks to fetal outcomes with their patients. Given the lack of data, caution is recommended when prescribing this medication to pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Cutiecaine (topical lidocaine cream). Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Cutiecaine (topical lidocaine cream). The prescribing information does not provide any recommendations for dosage adjustments, special monitoring, or precautions for individuals with compromised liver function. Therefore, healthcare providers should exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

Overdosage

In the event of an overdosage, it is imperative that medical attention is sought immediately. Healthcare professionals should advise patients or caregivers to contact their physician without delay if the substance has been ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a healthcare provider is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid using the medication in or near the eyes to prevent irritation or injury. It is important to instruct patients not to apply the medication in large amounts, especially over raw surfaces or blisters, as this may lead to adverse effects.

Patients should be informed to discontinue use and seek medical advice if they experience any allergic reactions, if their condition worsens or does not improve, if symptoms resolve and then return within a few days, or if they notice any signs of itching, redness, burning, swelling, or other concerning symptoms.

Additionally, healthcare providers should emphasize the importance of keeping both used and unused medication out of the reach of children and pets to prevent accidental ingestion or misuse. In the event that the medication is swallowed, patients should be instructed to seek medical attention immediately and to contact their doctor without delay.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity.

Both used and unused medicine must be kept out of the reach of children and pets to prevent accidental ingestion. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should be advised that the medication is for topical use only and should not be applied in or near the eyes. It is important to avoid using large amounts, especially on raw surfaces or blisters. Patients are instructed to discontinue use and consult a healthcare professional if they experience any allergic reactions, if their condition worsens or does not improve, or if symptoms reappear within a few days. Additionally, any occurrence of itching, redness, burning, swelling, or other adverse symptoms should prompt a consultation with a doctor.

Clinicians should emphasize the importance of keeping both used and unused medication out of reach of children and pets. In the event of accidental ingestion, patients should seek medical attention immediately by contacting their doctor.

Drug Information (PDF)

This file contains official product information for Cutiecaine, 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 Cutiecaine, 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

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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.