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Curacaine

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
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 2012
Label revision date
February 14, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
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 2012
Label revision date
February 14, 2017
Manufacturer
Transdermal Corp
Registration number
part348
NDC root
51350-012
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

Curacaine is a topical medication designed to provide temporary relief from pain and itching associated with various skin irritations. It is commonly used for conditions such as insect bites, sunburn, minor cuts, scrapes, burns, and other minor skin irritations. By applying Curacaine to the affected area, you can help soothe discomfort and promote healing.

This product works by numbing the skin and reducing the sensation of pain and itching, allowing you to feel more comfortable while your skin recovers. Remember, Curacaine is for external use only, so be sure to follow the application guidelines for the best results.

Uses

You can use this medication for temporary relief from various skin discomforts. It helps ease pain and itching, making it useful for insect bites, sunburn, minor cuts, scrapes, burns, and other minor skin irritations.

If you are pregnant or breastfeeding, it's important to consult a health professional before using this product to ensure it's safe for you and your baby.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for your little one. Always follow your healthcare provider's advice for the best outcomes.

What to Avoid

It's important to use this product safely. You should avoid using it in large quantities, especially on raw or blistered skin, as this could lead to irritation or other issues. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product to ensure it is safe for you and your baby.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes; if this happens, rinse your eyes with water immediately. Do not apply it in large amounts, especially on raw or blistered skin. If you are pregnant or breastfeeding, consult a healthcare professional before using it.

You should stop using the product and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If it does get into your eyes, rinse them with water immediately. Use it carefully and do not apply large amounts, especially on raw or blistered skin. If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. If you notice that your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 for personalized advice. They can help determine the best approach to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, as of now, this medication does not have known conflicts with other drugs or 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 new medications or tests with your healthcare provider to stay informed and to address any potential concerns. This proactive approach helps you manage your health better and avoid any unexpected issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place where the temperature stays between 58°F and 87°F (14°C to 31°C). It's important to keep it away from freezing temperatures, as well as direct heat or sunlight, which can damage the product.

When handling the product, always do so with care to maintain its integrity. Make sure to follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

No further information is available.

FAQ

What is Curacaine used for?

Curacaine is used for the temporary relief of pain and itching associated with insect bites, sunburn, minor cuts, scrapes, burns, and minor skin irritations.

How should I apply Curacaine?

For adults and children 2 years of age and older, apply to the affected area no more than 3 to 4 times daily. Consult a doctor for children under 2 years of age.

Are there any warnings for using Curacaine?

Yes, Curacaine is for external use only. Keep it out of your eyes, do not use in large quantities over raw surfaces or blistered areas, and consult a health professional if pregnant or breastfeeding.

What should I do if my symptoms persist?

Stop using Curacaine and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

What are the inactive ingredients in Curacaine?

Inactive ingredients include Caprylyl Glycol, Cetearyl Alcohol, Cyclopentasiloxane, and several others.

What should I do if I accidentally swallow Curacaine?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store Curacaine?

Store Curacaine between 58° - 87° F and protect it from freezing, direct heat, or sunlight.

Packaging Info

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

Packaging configurations for Curacaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Curacaine is a pharmaceutical formulation containing Lidocaine Hydrochloride as its active ingredient. The product is identified by the label Curacaine_Label_Primary_Lidocaine HCl and is referenced in the revision Curacaine_REV 061915_r3. The formulation is designed for medical use, adhering to established standards for safety and efficacy.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions. Specifically, it provides relief for insect bites, sunburn, minor cuts, scrapes, burns, and minor skin irritations.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to assess potential teratogenic effects. No nonteratogenic effects have been mentioned.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in patients who are pregnant or breastfeeding unless directed by a healthcare professional. Additionally, the product should not be applied in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes; in the event of contact, rinse thoroughly with water. The product should not be applied in large quantities, especially on raw surfaces or blistered areas. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

General precautions include keeping the product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should advise patients to discontinue use and seek medical advice if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept out of the eyes; in case of contact, it should be rinsed with water immediately. It is advised not to use the product in large quantities, especially over raw surfaces or blistered areas.

In the event that conditions worsen, or if symptoms persist for more than 7 days, patients are instructed to stop use and consult a healthcare professional. Additionally, if symptoms clear up and then recur within a few days, discontinuation of the product and consultation with a doctor is recommended.

For pregnant or breastfeeding individuals, it is essential to seek advice from a health professional before using the product.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Curacaine.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of exposure, is crucial for effective management and treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to emphasize that this product is for external use only. Patients should be informed to avoid contact with the eyes; if contact occurs, they should rinse the eyes with water to remove the product.

When using this product, patients should be cautioned against using it in large quantities, especially over raw surfaces or blistered areas. Additionally, pregnant or breastfeeding patients should be encouraged to consult a healthcare professional before using the product.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

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 58° to 87° F. Care must be taken to protect the product from freezing, as well as from direct heat and sunlight to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Curacaine, 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 Curacaine, 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.