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Cutiecaine

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 50 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 2011
Label revision date
November 15, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 50 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 2011
Label revision date
November 15, 2011
Manufacturer
Transdermal Corp
Registration number
part348
NDC root
51350-111
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 used to help reduce pain and discomfort associated with hemorrhoids, minor cuts, abrasions, minor burns, sunburns, insect bites, and poison ivy. It works by numbing the skin and relieving pain when a small amount (1 to 2 grams) is gently massaged onto the affected area.

If you have children under 2 years of age, it's important to consult a doctor before use. This ensures that the medication is appropriate and safe for their specific needs.

Uses

You can use this medication to help reduce pain and discomfort caused by hemorrhoids, including itching. It’s also effective for treating minor cuts, abrasions, minor burns, sunburns, insect bites, and reactions to poison ivy. To use it, simply apply a small amount (1 to 2 grams) to the affected area and gently massage it into the skin to numb the area or relieve pain. Just be sure not to cover the area after application.

If you have a child under 2 years old, it's important to consult your doctor before using this medication.

Dosage and Administration

If you're looking for relief from pain or discomfort caused by minor cuts, abrasions, burns (including sunburn), insect bites, poison ivy, or hemorrhoids, this medication can help. To use it, simply apply a small amount, about 1 to 2 grams, directly to the affected area of your skin. Gently massage it in to help numb the skin or relieve pain, but be careful not to cover the area with a bandage or wrap, as this can interfere with the medication's effectiveness.

If you have a child under 2 years old, it's important to consult your doctor before using this medication to ensure it's safe for them. Always follow these guidelines to get the best results and keep your skin comfortable.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would make the drug unsafe for you) or controlled substance classifications associated with it. Additionally, there are no known risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance) linked to this medication.

Since there are no specific "do not take" or "do not use" instructions, you can proceed with your treatment as directed by your healthcare provider. Always remember to discuss any concerns or questions with them to ensure the best outcomes for your health.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. It is crucial not to use it in or near your eyes, and avoid applying large amounts, especially on raw surfaces or blisters.

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, you should stop using the medication and consult your doctor. Additionally, if you experience itching, redness, burning, swelling, or any other concerning symptoms, seek medical advice promptly.

Warnings and Precautions

You should avoid using this medication in or near your eyes, and refrain from applying 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 to prevent accidental ingestion or misuse.

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 consult your doctor. Additionally, if you experience itching, redness, burning, swelling, or any other concerning symptoms, reach out to your healthcare provider.

In case of accidental swallowing, seek emergency medical help immediately by calling your doctor. Your safety is a priority, so please take these precautions seriously.

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 they may include unusual symptoms that you should be aware of. Always err on the side of caution and reach out for professional guidance if you suspect an overdose has occurred. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. Its use is generally not recommended because it may pose potential risks to your developing baby. If you are considering using this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if you do use this medication while pregnant, your healthcare provider may need to adjust the dosage to ensure safety. Always prioritize open communication with your healthcare team to make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Cutiecaine while nursing. The information available does not indicate any particular considerations or precautions you need to take while breastfeeding. Always consult with your healthcare provider if you have any concerns or questions about medications and breastfeeding.

Pediatric Use

If you have a child under 2 years old, it's important to consult your doctor before using this medication. This ensures that it is safe and appropriate for your little one.

Additionally, always keep both used and unused medicine out of reach of children and pets to prevent any accidental ingestion. Your vigilance helps keep your family safe.

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.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). Always keep both used and unused medicine safely out of the reach of children and pets to prevent any accidental ingestion or misuse.

When handling the product, make sure to maintain a clean environment to avoid contamination. Following these guidelines will help ensure the safety and effectiveness of your medicine.

Additional Information

This medication is applied directly to the skin (topical use). It's important to avoid using it near your eyes and not to apply it in large amounts, especially on raw surfaces or blisters. If you experience any allergic reactions, worsening of your condition, or if symptoms return after improvement, stop using the medication and consult your doctor. Additionally, be cautious to keep both used and unused medicine out of reach of children and pets. If the medication is swallowed, seek medical attention immediately.

FAQ

What is this medication used for?

This medication is used to reduce pain or discomfort from hemorrhoids, minor cuts, abrasions, minor burns, sunburns, insect bites, and poison ivy.

How should I apply this medication?

You should apply a small amount (1 to 2 gm) of this medication on the skin with a gentle massage to numb the skin or relieve pain. Do not occlude the area.

Is this medication safe for children?

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

Are there any warnings associated with this medication?

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

What should I do if I experience an allergic reaction?

If you experience an allergic reaction, or if your condition worsens and does not improve, you should stop using the medication and ask your doctor.

Can I use this medication during pregnancy?

Safety during pregnancy has not been established, and you should consult your healthcare provider for advice before use.

What should I do if I swallow this medication?

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

How should I store this medication?

Store this medication at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).

Packaging Info

Below are the non-prescription pack sizes of Cutiecaine (topical lidocaine (5% 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 "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the relief of pain and discomfort associated with hemorrhoids, including symptoms such as pain and itching. It is also indicated for the treatment of minor cuts, abrasions, minor burns, sunburns, insect bites, and reactions to poison ivy.

For application, a small amount (1 to 2 grams) of the medication should be gently massaged onto the affected skin area to achieve numbing or pain relief. It is important to avoid occlusion of the treated area.

Consultation with a healthcare professional is advised for the use of this medication in children under 2 years of age. There are no teratogenic or nonteratogenic effects associated with this drug.

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, and hemorrhoid-related 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 treated area.

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

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

The use of this medication requires careful consideration of the following warnings and precautions to ensure patient safety and efficacy.

Warnings

This medication is contraindicated for use in or near the eyes. Additionally, it should not be applied in large amounts, particularly over raw surfaces or blisters, to avoid potential adverse effects.

Stop Use and Consult a Healthcare Professional If

Patients should discontinue use and seek medical advice if any of the following occur: signs of allergic reactions, worsening of the condition without improvement, recurrence of symptoms after a brief period of resolution, or the emergence of itching, redness, burning, swelling, or other concerning symptoms.

Emergency Medical Help

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately. Patients should contact their healthcare provider without delay.

General Precautions

It is essential to keep both used and unused medication out of the reach of children and pets to prevent accidental ingestion or misuse. Proper storage and handling are critical to ensuring safety.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the recommendation to avoid application in or near the eyes, as well as the caution against using large amounts, particularly over raw surfaces or blisters.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience any allergic reactions. Additionally, if the condition being treated worsens or does not improve, or if symptoms resolve and then return within a few days, medical advice should be sought. Other symptoms that warrant discontinuation of use and consultation include itching, redness, burning, swelling, or any other unusual reactions.

These precautions are essential to ensure patient safety and to mitigate the risk of adverse effects during treatment.

Drug Interactions

There are no specific drug interactions identified for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Cutiecaine (topical lidocaine (5% 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 consult a healthcare professional prior to use. It is essential to keep both used and unused medication out of the reach of children and pets to ensure safety.

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

Safety during pregnancy has not been established for this medication. Use 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 healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and it is crucial to discuss any modifications with a healthcare provider. Pregnant women should use this medication only if clearly needed and after thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

Lactation

There are no specific warnings or recommendations regarding the use of Cutiecaine in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Therefore, healthcare professionals may consider the use of Cutiecaine in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in this population 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 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 attention is crucial. Healthcare professionals are advised to instruct patients to seek medical help without delay if the product is ingested.

Recommended Actions Patients should contact their healthcare provider or local poison control center immediately upon suspicion of an overdose. Prompt intervention is essential to mitigate potential adverse effects.

Potential Symptoms While specific symptoms of overdosage are not detailed, it is important for healthcare professionals to monitor for any unusual or severe reactions following ingestion.

Management Procedures Management of an overdose should be guided by clinical judgment and may involve supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to address any complications that may arise.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, itching, redness, burning, swelling, and other symptoms.

Patient Counseling

Healthcare providers should advise patients to keep both used and unused medicine out of the reach of children and pets. This precaution is essential to prevent accidental ingestion or misuse, ensuring the safety of vulnerable individuals in the household. It is important for patients to understand the potential risks associated with improper storage of medications and to take appropriate measures to secure them.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

It is essential to keep both used and unused medicine out of the reach of children and pets to ensure safety. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically. Clinicians should advise patients not to apply the product in or near the eyes and to avoid using large amounts, especially over raw surfaces or blisters. Patients are instructed to discontinue use and consult a healthcare provider if they experience allergic reactions, worsening conditions, or if symptoms reappear after initial improvement. Additionally, it is crucial to keep both used and unused medication out of reach of children and pets, and to seek immediate medical attention if the product is swallowed.

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.

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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.