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Bio-Scriptives Lidum

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 2.8 g/56 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
June 3, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.8 g/56 g
Other brand names
Dosage form
Cream
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 2010
Label revision date
June 3, 2011
Manufacturer
BioChemics, Inc
Registration number
part348
NDC root
60608-011
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

This medication provides rapid relief from pain and itching associated with various skin issues. It is commonly used for minor burns, skin irritations, scrapes, cuts, sunburn, and insect bites. By targeting the discomfort caused by these conditions, it helps you feel more comfortable and promotes healing.

Uses

You can use this medication for quick relief from pain and itching caused by various skin issues. It works rapidly to help soothe discomfort from minor burns, skin irritations, scrapes, cuts, sunburn, and insect bites.

This product is designed to provide temporary relief, making it a handy option for everyday skin irritations. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

If you or your child is 2 years old or older, you can use this medication by applying it directly to the affected areas of the skin. It's important to do this 3 to 4 times a day to ensure the best results. Make sure to follow the recommended frequency for effective treatment. Always wash your hands before and after applying the medication to keep the area clean and avoid spreading any infection.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never apply it in or near your eyes, as this can cause irritation or harm. Additionally, avoid using large amounts, especially on raw or blistered skin, as this could lead to adverse effects.

By following these guidelines, you can help ensure a safe and effective experience with the product. Always prioritize your health and well-being when using any medication.

Side Effects

This product is intended for external use only, so be sure to avoid applying it near your eyes or in large amounts, especially on raw or blistered skin.

If you experience an allergic reaction, or if your condition worsens or does not improve within 7 days of use, you should stop using the product immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. It's important to keep this product out of reach of children to ensure their safety.

If you experience an allergic reaction or if your condition worsens or does not improve within 7 days of use, you should stop using the product and contact your doctor for further guidance. Always prioritize your health and safety when using any medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is generally not recommended for use in pregnant women due to potential risks to the developing fetus. If you are considering using this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

There are no specific dosage adjustments for pregnant women, but special precautions are advised. You should only use this product if it is clearly needed and after a thorough discussion with your healthcare professional. Always prioritize your health and the health of your baby by seeking expert guidance.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of lidocaine cream while nursing. The information available does not indicate any concerns about the cream affecting your milk production or being passed into your breast milk.

As always, if you have any questions or concerns about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children aged 2 years and older, you should apply it externally to the affected areas of their skin three to four times a day. It's important to follow this guideline to ensure safe and effective use. Always monitor your child for any unusual reactions and consult your healthcare provider if you have any concerns.

Geriatric Use

While there is no specific information about the use of Bio-Scriptives Lidum (lidocaine cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions that may be present. Always prioritize safety and open communication with your healthcare team when it comes to medication use in older adults.

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 change 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 situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always share your complete list of medications and any tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically (on the skin) to the affected areas. For both adults and children aged 2 years and older, it is recommended to use it 3 to 4 times a day. Make sure to follow these guidelines for the best results.

FAQ

What is the primary use of this drug?

This drug provides rapid onset temporary relief of pain and itching due to minor burns, skin irritations, scrapes, cuts, sunburn, and insect bites.

Who can use this drug?

Adults and children 2 years and up can apply it externally to affected areas 3-4 times a day.

Are there any contraindications for this drug?

There are no specified contraindications, but it should not be used in or near the eyes or in large quantities over raw surfaces or blistered areas.

What should I do if I experience an allergic reaction?

You should stop using the drug if an allergic reaction occurs or if your condition worsens or does not improve within 7 days.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women without consulting a healthcare provider.

What precautions should nursing mothers take?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers mentioned.

How should I store this drug?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

What should I do if I accidentally use this drug in my eyes?

If the drug gets into your eyes, rinse them immediately with water and seek medical attention if irritation persists.

Packaging Info

Below are the non-prescription pack sizes of Bio-Scriptives Lidum (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bio-Scriptives Lidum.
Details

Drug Information (PDF)

This file contains official product information for Bio-Scriptives Lidum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication externally to the affected areas 3 to 4 times daily. It is important to ensure that the application is made to clean, dry skin. The frequency of application may be adjusted based on the severity of the condition and the response to treatment, but should not exceed the recommended dosing range. Care should be taken to avoid contact with eyes and mucous membranes during application.

Contraindications

Use of this product is contraindicated in the following situations:

Application in or near the eyes is prohibited due to the potential for irritation or damage to ocular tissues. Additionally, the product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application in or near the eyes. It should not be used in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects.

Healthcare professionals should advise patients to discontinue use immediately if an allergic reaction occurs. Additionally, if the condition worsens or does not show improvement within 7 days of use, patients should be instructed to stop using the product and seek medical advice.

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in or near the eyes and should not be applied in large quantities, particularly over raw surfaces or blistered areas.

In clinical practice, patients are advised to discontinue use if an allergic reaction occurs or if the condition worsens or does not improve within 7 days of application. These precautions are essential to ensure patient safety and to mitigate the risk of adverse reactions.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Bio-Scriptives Lidum (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bio-Scriptives Lidum.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to affected areas 3 to 4 times a day. There are no specific dosage adjustments indicated for this age group. Safety and efficacy have been established for children within this age range, aligning with the dosing recommendations for adults.

Geriatric Use

There is no specific information regarding the use of Bio-Scriptives Lidum (lidocaine cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks associated with its use. There may be risks to the fetus, and it is advised that pregnant patients consult a healthcare provider for guidance. No specific dosage modifications are provided for pregnant women. Pregnant women should use this product only if clearly needed and after a thorough discussion with a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine cream in lactating mothers. Additionally, there are no considerations or precautions related to lactation or the potential for excretion of lidocaine in breast milk. Therefore, healthcare professionals may consider the use of lidocaine cream in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is important to instruct patients not to use the medication in or near the eyes, as this could lead to irritation or injury.

Patients should be cautioned against using the medication in large quantities, especially on raw surfaces or blistered areas, to avoid potential adverse effects. They should be informed to discontinue use immediately if they experience any signs of an allergic reaction.

Additionally, healthcare providers should emphasize that if the patient's condition worsens or does not improve within 7 days of use, they should stop using the medication and seek further medical advice.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to protect the contents from light exposure, which can compromise the product's efficacy. Additionally, it is important to discard the product after opening to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Bio-Scriptives Lidum, 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 Bio-Scriptives Lidum, 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.