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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
December 3, 2025
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
December 3, 2025
Manufacturer
WellSpring Pharmaceutical Corporation
Registration number
M017
NDC root
65197-502
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 Burn Pain Relief is a topical medication designed to temporarily relieve pain and itching associated with various skin conditions. You can use it for sunburn, minor burns, minor cuts, scrapes, insect bites, and other minor skin irritations. This product is pharmacist recommended, ensuring that it meets quality standards for effective relief.

Additionally, Solarcaine is environmentally friendly as it contains no chlorofluorocarbons (CFCs), which are harmful to the ozone layer. This makes it a responsible choice for your skin care needs while providing the comfort you seek.

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 follow the usage instructions carefully. Misusing the product by inhaling it 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 in hot places; avoid temperatures above 40°C (104°F) to prevent any hazards. Your safety is paramount, so please adhere to these guidelines.

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 improves and then returns 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 be sure to apply it as directed and avoid using it in large amounts, especially on raw or blistered skin. Keep it away from your eyes, and never attempt to inhale the contents, as this can be very dangerous. Remember, the product is under pressure, so do not puncture or burn the container, and store it in a cool place, avoiding temperatures above 40°C (104°F).

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 contact your doctor. If you accidentally swallow any of the product, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

The product does not have specific information regarding its use during pregnancy. There are no explicit safety concerns, contraindications (situations where the product should not be used), or dosage changes recommended for pregnant individuals. Additionally, the insert does not mention any special precautions for use during this time.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Solarcaine Burn Pain Relief without specific warnings or recommendations against it. Currently, there is no information available about whether the ingredients in this product pass into breast milk or if they pose any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products while breastfeeding.

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 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 considering this medication, it’s important to consult with a healthcare provider. 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they may need to adjust your medications or monitor you more closely.

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, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can provide guidance based on your individual situation.

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 receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place, avoiding temperatures above 40°C (104°F). Prolonged exposure to high temperatures can compromise its quality.

When handling the product, be cautious not to puncture or incinerate it, as the contents are under pressure and could pose a safety risk. Always follow these guidelines to maintain the integrity of the product and ensure your safety.

Additional Information

When using this medication, it is important to apply it topically (on the skin) to the affected area no more than 3 to 4 times a day for adults and children aged 2 years and older. If the patient is under 2 years old, consult a doctor before use. For application on the face, spray the product into your palm first, then gently apply it to the skin.

Be aware that intentionally misusing this product by concentrating and inhaling it can be very dangerous and potentially fatal. Always use the medication as directed to ensure safety and effectiveness.

FAQ

What is Solarcaine Burn Pain Relief used for?

Solarcaine Burn Pain Relief 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, keep out of eyes, do not use in large quantities over raw surfaces or blistered areas, and avoid prolonged storage above 40°C (104°F).

What should I do if my condition worsens?

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 to use during pregnancy?

The product has not been specifically mentioned for use during pregnancy, and there are no special precautions provided.

Can I use Solarcaine while nursing?

There are no specific warnings or recommendations regarding the use of Solarcaine in nursing mothers.

What should I do if I accidentally swallow Solarcaine?

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

Is there any information on drug interactions with Solarcaine?

No drug interactions information is provided for Solarcaine.

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

No description information is available for the drug.

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 are advised 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 exceeding 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 recommended to spray the product into the palm of the hand and then gently apply it to the desired 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, do not puncture or incinerate the container, as the contents are under pressure. Prolonged storage above 40°C (104°F) should be avoided to maintain product integrity and safety.

Warnings and Precautions

For external use only, this product should not be applied in large quantities, especially on raw surfaces or blistered areas. Healthcare professionals must advise patients to avoid contact with the eyes and to use the product strictly as directed. Intentional misuse, such as deliberately concentrating and inhaling the contents, poses significant health risks and can be fatal.

It is imperative to inform patients that the product's contents are under pressure; therefore, they should not puncture or incinerate the container. Prolonged storage above 40°C (104°F) should be avoided to maintain product integrity.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects. When using this 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, patients should not puncture or incinerate the container, as it is under pressure, and prolonged storage above 40°C (104°F) should be avoided.

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 clear up and then recur within a few days. It is also crucial 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 should be made without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 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; consultation with a healthcare professional is advised. For children aged 2 years and older, the medication may be applied to the affected area up to 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been specifically mentioned for use during pregnancy. There are no explicit statements regarding safety concerns, contraindications, or dosage modifications for pregnant patients. Additionally, no special precautions regarding the use of this product during pregnancy are provided in the prescribing information. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 these contexts.

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 inform patients that the product should not be applied in large quantities, especially over raw surfaces or blistered areas.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be made aware that if symptoms resolve and then reoccur within a few days, they should also stop use and seek medical advice.

Providers should emphasize the importance of keeping the product out of the eyes and using it only as directed. Patients must be cautioned against intentional misuse, as deliberately concentrating and inhaling the contents can be harmful or even fatal. Furthermore, patients should be informed not to puncture or incinerate the container, as it is under pressure. They should also avoid prolonged storage above 40°C (104°F) to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a controlled environment, avoiding prolonged exposure to temperatures exceeding 40°C (104°F) to maintain its integrity and efficacy.

The container must not be punctured or incinerated, as the contents are under pressure. Proper handling procedures should be followed to ensure safety and compliance with storage guidelines.

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 not exceeding 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, the product should not be used without consulting a doctor. When applying to the face, it is advised to spray the product into the palm of the hand before gently applying it to the skin.

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.

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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.