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Syren Intimate Relief

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Active ingredient
Lidocaine Hydrochloride 40 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 2017
Label revision date
September 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 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 2017
Label revision date
September 25, 2024
Manufacturer
Icon Health Science
Registration number
M017
NDC root
69233-843
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 associated with cuts, scrapes, and minor skin irritations. It can be a helpful option for soothing discomfort and promoting healing in these common skin issues.

Typically available in a 1oz (30ml) package, this product is easy to use and can be a supportive addition to your first aid supplies. If you experience minor skin injuries, this medication may help alleviate your symptoms effectively.

Uses

You can use this medication for the temporary relief of pain and itching associated with cuts, scrapes, and 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) or nonteratogenic effects associated with this medication. This makes it a safe option for managing minor skin problems.

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 the person needing treatment is under twelve years old, it’s important to consult a physician (doctor) before using the medication. This will help ensure that it’s safe and appropriate for their specific needs.

What to Avoid

It's important to use this medication safely. You should not apply it to wounds or damaged skin, as this can lead to complications. After using the medication, make sure to wash your hands thoroughly to avoid any unintended contact with other areas of your body or with others.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, following the usage instructions carefully is essential for your safety and well-being.

Side Effects

When using this product, it's important to be aware of some key safety information. It is for external use only, so avoid contact with your eyes. If your symptoms last more than seven days, you should stop using it. Keep it out of reach of children, and if swallowed, consult a physician immediately.

You should not apply this product to wounds or damaged skin, and remember to wash your hands after use. If you are pregnant or breastfeeding, please contact your physician before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any wounds and damaged skin. After using the product, make sure to wash your hands thoroughly. If you accidentally swallow it, consult your doctor right away.

If your symptoms last longer than seven days, stop using the product and reach out to your healthcare provider. Additionally, if you are pregnant or breastfeeding, it's important to talk to your doctor before using this product to ensure it's safe for you.

Overdose

If you or someone you know has swallowed too much of this medication, it’s important to consult a physician right away. Overdosing can lead to serious health issues, and getting professional help is crucial.

Signs of an overdose may include unusual symptoms that could affect your breathing or overall well-being. If you notice any concerning changes, don’t hesitate to seek immediate medical attention. Remember, it’s always better to be safe and get checked by a healthcare professional.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby stay safe. Always prioritize open communication with your physician 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 your healthcare provider can help ensure that you and your baby remain safe and healthy while considering any potential risks associated with the medication. Always prioritize open communication with your physician regarding your health and breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged two years and older, you can apply the medication to the affected area up to three to four times a day. However, if your child is under twelve years old, it's essential to consult a physician (doctor) before use to ensure safety and proper dosage.

Always prioritize your child's health by seeking professional advice when needed, especially for younger children.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help you understand how your kidney health may affect your medications and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

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 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 it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than three to four times a day if you are an adult or a child aged two years or older. If the patient is under twelve years old, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain and itching, cuts, scrapes, and minor skin irritations.

How should I apply the drug?

Adults and children two years of age or older should apply it to the affected area not more than three to four times daily. Children under twelve years of age should consult a physician.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I avoid while using this drug?

You should not apply it to wounds or damaged skin and should wash your hands after use.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if I accidentally swallow the drug?

If swallowed, consult a physician immediately.

What are the warnings associated with this drug?

This drug is for external use only, should avoid contact with eyes, and if symptoms persist for more than seven days, you should discontinue use.

How should I store this drug?

Store the drug at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Syren Intimate Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Syren Intimate Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is packaged in a 1 oz (30 mL) container. The effective date of the labeling is August 28, 2017. The package includes a carton label and an inner label, both of which are represented in the accompanying images. The carton label is identified as "NewCarton," and the inner label is referred to as "InnerLabel." The images are in JPEG format and provide visual details of the product's packaging.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with cuts, scrapes, and 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 frequency is three to four times daily to the affected area. It is advised that children under twelve years of age consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

Use of this product is contraindicated in patients with wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is advised to wash hands thoroughly after application to prevent unintended exposure or contamination.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a healthcare professional should be consulted.

In cases of accidental ingestion, it is essential to seek medical advice promptly. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. To ensure safety, individuals are advised to wash their hands thoroughly after application.

Pregnant or breastfeeding individuals should consult their physician prior to use to assess any potential risks associated with the product.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. If symptoms persist for more than seven days, patients are advised to discontinue use and consult a healthcare professional.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical advice promptly. Patients should not apply the product to wounds or damaged skin, and it is recommended that hands be washed thoroughly after application to prevent unintended exposure.

For individuals who are pregnant or breastfeeding, it is essential to contact a physician prior to use to ensure safety for both the patient and the child.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Syren Intimate Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Syren Intimate Relief.
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 twelve years of age, it is advised to consult a physician prior to use.

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

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure optimal fetal outcomes.

Lactation

Lactating mothers are advised to contact their 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 when considering this medication for lactating patients.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted in these patients to ensure their safety while on treatment.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

Prompt medical evaluation is essential to assess the severity of the situation and to initiate appropriate management strategies. Symptoms of overdosage may vary depending on the specific circumstances and the amount ingested, thus thorough monitoring and supportive care may be required.

Healthcare providers should ensure that the patient receives comprehensive care, which may include symptomatic treatment and supportive measures as deemed necessary by the attending physician. It is crucial to follow established protocols for managing overdosage to mitigate potential risks and complications effectively.

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 consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin to prevent potential complications. Additionally, patients should be instructed to wash their hands thoroughly after using the product to ensure safety and hygiene.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged two years or older being three to four times daily to the affected area. For children under twelve years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Syren Intimate Relief, 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 Syren Intimate Relief, 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.