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Inked Science Lidocaine 4 Percent

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 2.24 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 2020
Label revision date
February 25, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.24 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 2020
Label revision date
February 25, 2022
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-960
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

INKED SCIENCE LIDOCAINE NUMBING CREAM is a topical cream designed to help reduce pain or discomfort associated with various skin irritations. This includes conditions like sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns.

By applying this cream to the affected area, you can experience relief from the discomfort caused by these skin issues, allowing for a more comfortable healing process.

Uses

You can use this medication to help relieve pain or discomfort from various skin irritations. This includes issues like sunburn, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It is also effective for soothing minor cuts, scratches, and burns.

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 or your child is 2 years old or older, you can apply the medication directly to the affected area of the skin. You should do this up to 3 to 4 times a day, depending on your needs. Make sure to follow the instructions carefully to ensure the best results.

If your child is under 2 years old, it's important to consult with a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always prioritize safety and follow professional advice when it comes to medication use.

What to Avoid

It's important to use this product safely. You should never apply it in or near your eyes, as this can cause irritation or damage. Additionally, avoid using large amounts, especially on raw surfaces or blistered areas, to prevent potential complications.

By following these guidelines, you can help ensure a safer experience with the product. If you have any questions or concerns about its use, please consult a healthcare professional.

Side Effects

If you experience an allergic reaction (a serious response by your immune system) while using this product, it's important to stop using it and consult a doctor. Additionally, you should seek medical advice if your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other concerning symptoms.

Remember, this product is for external use only, so please use it as directed.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it out of reach of children, and if it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if you experience an allergic reaction, if your condition worsens or does not improve within 7 days, if symptoms improve and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other concerning symptoms.

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 using this medication during pregnancy has not been established. It is generally not recommended for 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.

Additionally, if you do use this medication while pregnant, your healthcare provider may need to adjust the dosage. Always prioritize open communication with your healthcare provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is passed into breast milk or if it poses any risk to your infant.

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

Pediatric Use

When using this medication for children, you can apply it externally to the affected area up to 3 to 4 times a day for kids aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so following these guidelines is essential.

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 considering this medication, it’s important to consult with a healthcare provider. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

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

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 any other medications or supplements you might be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20 and 25° C (68 to 77° F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with regulations.

Additional Information

No further information is available.

FAQ

What is INKED SCIENCE LIDOCAINE NUMBING CREAM used for?

INKED SCIENCE LIDOCAINE NUMBING CREAM is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns.

How should I use this cream?

For adults and children 2 years and older, apply the cream externally to the affected area up to 3 to 4 times a day. For children under 2 years, consult a doctor.

Are there any precautions I should take when using this cream?

Do not use the cream in or near the eyes, and avoid using it in large quantities, especially over raw surfaces or blistered areas.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, or if the condition worsens or does not improve within 7 days, stop using the cream and consult a doctor.

Is it safe to use this cream during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks to the fetus. Consult your healthcare provider for advice.

What should I do if the cream is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store this cream?

Store the cream at a temperature between 20 - 25° C.

Packaging Info

Below are the non-prescription pack sizes of Inked Science Lidocaine 4 Percent (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inked Science Lidocaine 4 Percent.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is presented in a professional labeling format, featuring a product label and product box that adhere to industry standards. The labeling includes an "Inked Science" box, which is designed to provide essential information in a clear and concise manner. Additionally, the label art incorporates the "Inked Science" theme, ensuring a cohesive visual identity that aligns with the product's scientific focus.

Uses and Indications

This drug is indicated for the reduction of pain or discomfort associated with skin irritations, including but not limited to sunburn, insect bites, poison ivy, poison oak, poison sumac, as well as minor cuts, scratches, and burns.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication externally to the affected area up to 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a physician before administration.

Contraindications

Use is contraindicated in or near the eyes due to the potential for irritation or damage. Additionally, application in large quantities, particularly over raw surfaces or blistered areas, is contraindicated to prevent exacerbation of the condition or adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative to keep it out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after they have resolved, or the emergence of redness, irritation, swelling, pain, or any other concerning symptoms. Monitoring for these adverse effects is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event of an allergic reaction, patients are advised to stop use and consult a healthcare professional.

Additionally, patients should seek medical advice if their condition worsens or does not improve within 7 days of use. If symptoms initially clear up but then return within a few days, it is also recommended to stop use and contact a doctor. Other concerning signs that warrant medical consultation include the onset of redness, irritation, swelling, pain, or any other unusual symptoms.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Inked Science Lidocaine 4 Percent (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inked Science Lidocaine 4 Percent.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to 3 to 4 times a day. For children under 2 years of age, it is advised to consult a doctor before use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant patients, and any modifications should be made in consultation with a healthcare provider. Pregnant women should use this product only if clearly needed and after a thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate management strategies.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are key components in the management of suspected overdose cases.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if they experience any allergic reactions, if their condition worsens or does not improve within 7 days, if symptoms resolve and then return within a few days, or if they notice any redness, irritation, swelling, pain, or other concerning symptoms.

It is important to inform patients that they should avoid using the product in or near the eyes to prevent irritation. Additionally, patients should be cautioned against using large quantities of the product, especially on raw surfaces or blistered areas, to minimize the risk of adverse effects.

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 a controlled temperature range of 20 to 25° C. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Inked Science Lidocaine 4 Percent, 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 Inked Science Lidocaine 4 Percent, 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.