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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
June 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
June 26, 2024
Manufacturer
WellSpring Pharmaceutical Corporation
Registration number
M017
NDC root
65197-512
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

Solarcaine After Sun Pain Relief is a topical product designed to provide temporary relief from pain and itching caused by sunburn, minor burns, minor cuts, scrapes, insect bites, and other minor skin irritations. It is a popular choice among consumers, being the #1 pharmacist-recommended option according to Pharmacy Times and U.S. News & World Report for 2023-2024.

This product is formulated without chlorofluorocarbons (CFCs), which are harmful to the ozone layer, making it a more environmentally friendly choice for soothing your skin after sun exposure or minor injuries.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for soothing discomfort from sunburn, minor burns, minor cuts, scrapes, insect bites, and other minor skin irritations.

This product is designed to help you feel more comfortable when dealing with these common skin problems, allowing you to get back to your daily activities with less discomfort.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. 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. However, if your child is under 2 years old, it’s important not to use this medication without consulting a doctor first.

When applying the medication to your face, spray it into the palm of your hand first, then gently apply it to the affected area. This method helps ensure that the medication is applied safely and effectively.

What to Avoid

It's important to use this product safely to avoid serious risks. Do not apply it in large amounts, especially on raw or blistered skin. Always keep it away from your eyes and use it only as directed. Misusing the product by inhaling it intentionally can be very dangerous and even lead to death.

Additionally, never puncture or burn the container, as it is under pressure. Be cautious about storing it; avoid keeping it in places where the temperature exceeds 40°C (104°F). Following these guidelines will help ensure your safety while using this product.

Side Effects

When using this product, it's important to follow the directions carefully. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. Misusing the product by inhaling it can be very dangerous and even fatal. Additionally, do not puncture or burn the container, as it is under pressure. Store it in a cool place, away from temperatures above 104°F (40°C).

If your condition worsens, lasts more than seven days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of skin, especially over raw or blistered surfaces. When applying, be careful to keep it away from your eyes and use it strictly as directed. Misusing the product by inhaling it can be very dangerous, and the contents are under pressure, so do not puncture or burn the container. Also, try to store it in a cool place, as prolonged exposure to temperatures above 104°F (40°C) can be harmful.

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

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's reassuring to know that there are no specific warnings, precautions, or dosage changes mentioned for Solarcaine Burn Pain Relief in relation to pregnancy. This means that, based on the available information, it is considered safe to use as directed during this time. However, it's always a good idea to consult with your healthcare provider before using any medication to ensure it aligns with your individual health needs and circumstances.

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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so 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 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 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 need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it in a cool place, avoiding temperatures above 40°C (104°F) for extended periods. This helps maintain its quality and performance.

When handling the product, please remember not to puncture or incinerate it, as it contains pressurized contents that could be dangerous. Following these guidelines will help you use the product safely and effectively.

Additional Information

There are a few important points to keep in mind regarding the use of this medication. It is applied topically (on the skin) and can be used by adults and children aged 2 years and older, with a recommended application of no more than 3 to 4 times daily. However, if the patient is under 2 years old, you should consult a doctor before use.

Be aware that intentionally misusing this medication, such as by concentrating and inhaling it, can be very dangerous and potentially fatal. Always use the medication as directed to avoid serious risks.

FAQ

What is Solarcaine After sun pain relief used for?

Solarcaine temporarily relieves pain and itching due to sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I use Solarcaine?

Shake well before use. Apply to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, use only as directed. Keep out of eyes, do not puncture or incinerate, and avoid prolonged storage above 40°C (104°F).

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition gets worse, symptoms last more than 7 days, or if symptoms clear up and occur again in a few days.

Is Solarcaine safe for use during pregnancy or while nursing?

There are no specific pregnancy-related warnings or recommendations for nursing mothers mentioned for Solarcaine.

What should I do if I accidentally swallow Solarcaine?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Does Solarcaine contain any harmful substances?

Solarcaine contains no CFCs, which are known to deplete the ozone layer.

Packaging Info

Below are the non-prescription pack sizes of Solarcaine Burn Pain Relief 4oz. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Solarcaine Burn Pain Relief 4oz.
Details

Drug Information (PDF)

This file contains official product information for Solarcaine Burn Pain Relief 4oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product identified by SPL code 34089-3 is formulated without chlorofluorocarbons (CFCs), thereby ensuring it does not contribute to the depletion of the ozone layer.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use. 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.

For children under 2 years of age, the product should not be used unless directed by a physician.

When applying to the face, it is advised to spray the product into the palm of the hand first, followed by gentle application to the facial area.

Contraindications

Use of this product is contraindicated in the following situations:

Application in large quantities, particularly over raw surfaces or blistered areas, is not recommended due to the potential for adverse effects.

The product should be kept out of the eyes to prevent irritation or injury.

It is essential to use the product only as directed; intentional misuse, such as deliberately concentrating and inhaling the contents, can be harmful or fatal.

Additionally, the product must not be punctured or incinerated, as it contains pressurized contents. Prolonged storage above 40°C (104°F) should also be avoided to maintain product integrity and safety.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, particularly over raw surfaces or blistered areas.

When using this product, it is imperative to keep it out of the eyes and to use it only as directed. Intentional misuse, such as deliberately concentrating and inhaling the contents, can be harmful or even fatal. The product is under pressure; therefore, it must not be punctured or incinerated. Prolonged storage above 40°C (104°F) should be avoided to maintain product integrity.

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

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

Side Effects

Patients using this product should be aware that it is for external use only. It is crucial to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects. When applying the product, patients must take care to keep it out of the eyes and use it only as directed. Intentional misuse, such as deliberately concentrating and inhaling the contents, can be harmful or even fatal. Additionally, the product should not be punctured or incinerated, as it contains contents under pressure. Prolonged storage above 40°C (104°F) should also be avoided to prevent potential hazards.

Patients are advised to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to keep the product out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center is recommended.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Solarcaine Burn Pain Relief 4oz. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Solarcaine Burn Pain Relief 4oz.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; healthcare professionals are advised to consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no 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

There are no specific pregnancy-related warnings, precautions, or dosage modifications associated with the use of Solarcaine Burn Pain Relief. Healthcare professionals should consider the absence of data regarding potential risks or fetal impacts when prescribing this medication to pregnant patients. As with any medication, the benefits and risks should be carefully weighed, particularly in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

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

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential harm.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be cautioned to stop using the product and seek medical advice if symptoms improve and then recur within a few days.

When using this product, patients must be reminded to avoid contact with the eyes. It is essential to emphasize that the product should be used only as directed, as intentional misuse by concentrating and inhaling the contents can be harmful or even fatal.

Patients should also be warned against puncturing or incinerating the container, as it is under pressure. They should be advised to avoid prolonged storage above 40°C (104°F) to ensure safety and efficacy.

Storage and Handling

The product is supplied in a pressurized container, and it is essential to avoid prolonged storage above 40°C (104°F) to maintain its integrity and efficacy. The container must not be punctured or incinerated, as it is under pressure. Proper handling and storage conditions are crucial to ensure safety and effectiveness.

Additional Clinical Information

Intentional misuse of the product by concentrating and inhaling its contents can lead to harmful or fatal consequences. The recommended route of administration is topical, with application to the affected area not exceeding 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, use is not advised without consulting a doctor.

No further information is available regarding laboratory tests, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Solarcaine Burn Pain Relief 4oz, 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 Solarcaine Burn Pain Relief 4oz, 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.