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Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
December 31, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Lotion
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 2018
Label revision date
December 31, 2024
Manufacturer
Sato Pharmaceutical Co. , Ltd.
Registration number
M017
NDC root
49873-618
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

You may be looking for a medication that provides temporary relief from pain and itching. This drug works by targeting the sensations associated with discomfort, helping to ease your symptoms when you need it most. It's important to use it as directed to ensure you get the best results. If you have any questions about how it works or its uses, feel free to ask a healthcare professional for more information.

Uses

You can use this medication for the temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage your symptoms.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

If you are caring for a child under 12, it's important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger patients.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should avoid contact with your eyes, and if you notice that your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, it's best to stop using the product and consult a doctor. Additionally, if you develop a rash or irritation, seek medical advice.

Please remember that this product is for external use only and should not be applied in large quantities, especially on raw or blistered areas. Also, keep it away from fire and flames, as it is flammable.

Warnings and Precautions

This product is for external use only and is flammable, so be sure to keep it away from fire and flames. When using it, avoid applying large amounts, especially on raw or blistered skin, and take care to keep it out of your eyes.

If your condition worsens, symptoms last longer than 7 days, clear up and then return within a few days, or if you develop a rash or irritation, stop using the product and contact your doctor. If you accidentally swallow it, seek 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 act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to appear; getting help right away can make a significant difference. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

When it comes to using Satohap Lidocaine Hydrochloride 4% Pain Relieving Lotion during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for pain relief during this time. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and recommendations based on your individual situation. They can help you understand any potential risks or considerations related to your health and your baby's well-being. Always prioritize open communication with your healthcare team to ensure the best outcomes for both you and your child.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without consulting a doctor first. For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit it to 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 may affect you if you have hepatic impairment (liver issues).

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, 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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from direct sunlight. This helps protect it from damage caused by heat and light. Always keep the lid tightly closed when not in use to maintain its integrity and prevent contamination.

Handling the product safely is also important. Make sure to follow these storage guidelines consistently to ensure that it remains effective and safe for your use.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching.

How should adults and children 12 years and older use this drug?

Apply to the affected area not more than 3 to 4 times daily.

Can children under 12 years of age use this drug?

No, do not use in children under 12 years of age; consult a doctor.

What precautions should I take when using this product?

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

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if a rash or irritation develops.

Is this drug flammable?

Yes, this drug is flammable; keep it away from fire and flame.

What should I do if I accidentally swallow this drug?

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

Is there any specific information regarding use during pregnancy or lactation?

There is no specific information provided regarding the use of this drug during pregnancy or lactation.

How should I store this drug?

Store with the lid tightly closed and avoid direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Lidocaine Lotion is identified by the SPL code 34089-3. The effective date of the insert is November 19, 2018. This product is packaged in a carton, which is visually represented in the image titled SatohapLidocaineLotion.jpg.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 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 12 years of age, the product should not be used unless directed by a healthcare professional. In such cases, it is advisable to consult a doctor for appropriate guidance and recommendations.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire and flame to prevent any risk of ignition.

General precautions should be observed when using this product. It is advised not to apply it in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects. Additionally, care should be taken to avoid contact with the eyes during application.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if a rash or irritation develops.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate management and care.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire and flame. It is advised not to use the product in large quantities, especially over raw surfaces or blistered areas.

While using this product, patients should avoid contact with the eyes. If any adverse reactions occur, such as worsening of the condition, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended to stop use and consult a doctor. Additionally, if a rash or irritation develops, patients should discontinue use and seek medical advice.

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 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

There is currently no information available regarding the use of Satohap Lidocaine Hydrochloride 4% Pain Relieving Lotion in pregnant patients. As such, the safety of this medication during pregnancy has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

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

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects. It is important for patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if they develop a rash or irritation.

Additionally, healthcare providers should remind patients to avoid contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, avoiding direct sunlight exposure to maintain its efficacy. The container must be kept tightly closed when not in use to prevent contamination and degradation. Proper handling and storage conditions are crucial for ensuring the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving, 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 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving, 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.