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Serum X

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Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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
December 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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
December 11, 2024
Manufacturer
AO Biologix, LLC
Registration number
M017
NDC root
82317-001
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

Serum X is a pain relief gel designed to provide temporary relief from pain. It contains lidocaine, which is a fast-acting medication that helps numb the area where it is applied. In addition to its pain-relieving properties, Serum X also has antioxidant properties, which can be beneficial for skin health.

This gel comes in a 30mL (1 Fl. oz.) container, making it easy to use whenever you need quick relief from discomfort.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, so it is considered safe in that regard. Additionally, there are no reported nonteratogenic effects, ensuring that it is generally well-tolerated.

Dosage and Administration

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. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure that it is safe and appropriate for their specific needs. Always follow your healthcare provider's advice for the best care.

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, please consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult your doctor if your condition worsens, if you experience any allergic reactions, or if your symptoms persist for more than seven days or return shortly after improvement. Additionally, avoid contact with your eyes and do not apply it in large amounts, especially on raw or blistered skin.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. 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 intended for external use only, so please avoid using it on large areas of skin, especially over raw or blistered surfaces. While using the product, be careful not to let it come into contact with your eyes.

If your condition worsens, you experience any allergic reactions, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, 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 immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Remember, it's always better to be safe and get professional advice if you suspect an overdose. Don't hesitate to reach out for help.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be 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

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

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 should be used if you have hepatic impairment (issues with liver function).

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 determine the best course of action based on your individual situation.

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 changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place away from direct light. This helps maintain its effectiveness and prevents any degradation. Additionally, the packaging is designed to be child-resistant, providing an extra layer of safety for households with young children.

Always handle the product with care, and make sure to follow any specific instructions provided for its use. Proper storage and handling are key to ensuring that the product remains safe and effective for you.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Serum X?

Serum X is a pain relief gel that provides temporary relief of pain and has antioxidant properties.

How does Serum X work?

Serum X contains fast-acting lidocaine, which helps to relieve pain quickly.

Who can use Serum X?

Adults and children 2 years of age and older can use Serum X. Children under 2 years should consult a doctor.

How should I apply Serum X?

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

Are there any contraindications for Serum X?

No specific contraindications are mentioned for Serum X.

What should I avoid while using Serum X?

Avoid using Serum X in large quantities, particularly over raw surfaces or blistered areas, and avoid contact with the eyes.

What should I do if my condition worsens while using Serum X?

Stop using Serum X and ask a doctor if your condition worsens, if any allergic reaction occurs, or if symptoms persist for more than 7 days.

Is Serum X safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Serum X.

How should I store Serum X?

Store Serum X in a cool, dry place away from light, and keep it out of reach of children.

What should I do if Serum X is swallowed?

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

Packaging Info

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

Packaging configurations for Serum X.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

AO Biologix Serum X is a pain relief gel formulated with fast-acting lidocaine. This product is designed to provide effective relief from pain while incorporating antioxidant properties. It is available in a 30 mL (1 Fl. oz.) dosage form, suitable for topical application.

Uses and Indications

This drug is indicated for the temporary relief of pain.

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

Dosage and Administration

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. It is important to ensure that the application is performed gently and that the area is clean prior to use.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

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

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

When using this product, it is imperative to avoid contact with the eyes. In the event of any adverse reactions, users should discontinue use and consult a healthcare professional if the condition worsens, if any allergic reaction occurs, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

It is essential to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to avoid applying the product in large quantities, particularly over raw surfaces or blistered areas, as this may increase the risk of adverse reactions.

Common adverse reactions may include local irritation or allergic reactions. Patients are advised to stop using the product and consult a healthcare professional if any allergic reaction occurs, if the condition worsens, or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought.

Care should be taken to avoid contact with the eyes during application. In the event of accidental contact, patients should rinse the eyes thoroughly with water and seek medical attention if irritation persists.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product to ensure safety for both the mother and child.

This product should be kept out of reach of children. In the case of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is advised.

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 Serum X (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Serum X.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the medication may be applied 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 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 consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. 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 drug. 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 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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 keep this product out of the reach of children. 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. It is important to inform patients to discontinue use and consult a doctor if their condition worsens or if they experience any allergic reactions.

Additionally, patients should be advised to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. Providers should also emphasize the importance of avoiding contact with the eyes while using this product.

Storage and Handling

The product is supplied in a child-resistant package designed to ensure safety during storage and handling. It is essential to store the product in a cool, dry place, away from direct light to maintain its integrity and effectiveness. Proper storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Serum X, 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 Serum X, 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.