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Sclera Care Topical Anesthetic Gel

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Active ingredient
Lidocaine Hydrochloride 30 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
November 5, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 30 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2022
Label revision date
November 5, 2023
Manufacturer
ScleraCare, LLC
Registration number
M017
NDC root
73698-281
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 designed to provide temporary relief from pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. It helps soothe discomfort and promotes a sense of relief, allowing you to feel more comfortable while your skin heals.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, or other minor skin irritations. It helps soothe discomfort and promotes healing in these common skin issues.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child who is at least two years old, you can apply this medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

If your child is under two years old, it's important to consult a physician (doctor) before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safe and effective treatment.

What to Avoid

It's important to use this medication safely. You should never apply it to wounds or damaged skin, and avoid bandaging tightly over the area. Additionally, do not use it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be ingested. Avoid getting it in your eyes, and do not apply it to wounds or damaged skin. If you notice that your symptoms last longer than seven days, please stop using the product and consult a doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, if you are pregnant or breastfeeding, it's advisable to speak with your doctor before using this product.

Warnings and Precautions

This product is meant for external use only, so please do not ingest it. Be careful to avoid getting it in your eyes. When using the product, do not apply it in large amounts, especially on raw or blistered skin.

If your symptoms last longer than seven days, it's important to stop using the product and consult your doctor. Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Avoid applying it to wounds or damaged skin, and do not wrap the area tightly with a bandage.

If you are pregnant or breastfeeding, please talk to your doctor before using this product to ensure it is safe for you.

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

If you are pregnant or breastfeeding, it is important to contact your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Consulting with a healthcare professional can help ensure the safety of both you and your baby. They can provide guidance on any potential risks or effects related to breastfeeding, including how the medication may impact your milk production or your infant's health. Always prioritize open communication with your healthcare provider during this time.

Pediatric Use

When using this medication for children, you can apply it to the affected area no more than three to four times a day if your child is two years old or older. However, if your child is under two years of age, it’s important to consult a physician (doctor) before use. Always remember to keep the medication out of reach of children to ensure their safety.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney problems). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help monitor your kidney function and make any necessary adjustments to your medication regimen.

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 (liver issues).

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 help you understand how to manage your treatment effectively.

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 provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and tests you are undergoing. This helps them monitor your health effectively and avoid any potential issues that could arise from combining treatments or tests. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling techniques, please refer to the guidelines provided with your product.

Additional Information

You can apply this medication to the affected area three to four times a day if you are an adult or a child aged two years or older. If your child is under two years old, it's important to consult a physician before use.

If you are pregnant or breastfeeding, make sure to contact your doctor before using this medication. If your symptoms last more than seven days, stop using the product and consult a doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately.

FAQ

What is this drug used for?

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

How should I apply this drug?

Adults and children two years of age or older should apply it to the affected area no more than three to four times daily. For children under two years of age, consult a physician.

Are there any contraindications for this drug?

Do not apply this drug to wounds or damaged skin, and do not bandage tightly.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist for more than seven days.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, contact a physician prior to use.

What should I do if this drug is swallowed?

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

What precautions should I take while using this drug?

Avoid contact with eyes and do not use in large quantities, particularly over raw surfaces or blistered areas.

How should I store this drug?

Store the drug at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Sclera Care Topical Anesthetic Gel (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sclera Care Topical Anesthetic Gel.
Details

Drug Information (PDF)

This file contains official product information for Sclera Care Topical Anesthetic Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a sterile solution for injection, identified by SPL Code 34089-3. It contains the active ingredient: insert active ingredient name here. The solution is clear and colorless, with a pH of insert pH value here. It is supplied in a insert packaging details here. Inactive ingredients include: insert inactive ingredients here.

Uses and Indications

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

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

Dosage and Administration

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

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Application of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, it is contraindicated to bandage tightly, as this may compromise circulation.

Use of the product in large quantities, particularly over raw surfaces or blistered areas, is also contraindicated to prevent exacerbation of the condition and to minimize the risk of further skin damage.

Warnings and Precautions

The product is intended solely for external use and must not be ingested. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

It is crucial to refrain from using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects. Should symptoms persist beyond seven days, patients are instructed to discontinue use and consult a physician for further evaluation.

To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Additionally, the product should not be applied to wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied.

For individuals who are pregnant or breastfeeding, it is essential to contact a physician prior to using this product to assess any potential risks.

Side Effects

Patients using this product should be aware that it is intended for external use only and is not meant for ingestion. Care should be taken to avoid contact with the eyes. The product should not be applied in large quantities, especially over raw surfaces or blistered areas.

In clinical practice, if symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician. It is crucial to keep the product out of reach of children; in the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is recommended.

Additionally, the product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly after application. Pregnant or breastfeeding individuals should consult a physician prior to using this product to ensure safety.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Sclera Care Topical Anesthetic Gel (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sclera Care Topical Anesthetic Gel.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use. Additionally, the product should be kept out of reach of children 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

Pregnant patients and those who are breastfeeding should contact a physician prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when making treatment decisions in this population.

Lactation

Lactating mothers are advised to contact a physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding 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 advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment 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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 apply the product to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be informed to avoid tightly bandaging the area where the product is applied.

Patients should be cautioned against using the product in large quantities, especially over raw surfaces or blistered areas, to prevent potential complications. They should also be advised to discontinue use and consult a doctor if symptoms persist for more than seven days, as this may indicate a need for further evaluation. Furthermore, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

Patients aged two years and older are advised to apply the medication to the affected area no more than three to four times daily. For children under two years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to contact a physician if they are pregnant or breastfeeding before using the product. Patients should also be instructed to discontinue use and seek medical advice if symptoms persist for more than seven days. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Sclera Care Topical Anesthetic Gel, 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 Sclera Care Topical Anesthetic Gel, 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.