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Inkorporated Numbing

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
September 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
September 17, 2025
Manufacturer
Prodigy Media Inc
Registration number
M017
NDC root
70171-0028
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 is designed to provide temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and various skin irritations. It helps soothe discomfort, allowing you to feel more comfortable while your skin heals. If you're dealing with any of these issues, this product may be a helpful option for you.

Uses

You can use this medication for the temporary relief of pain and itching caused by sunburns, minor cuts, insect bites, and various skin irritations. It helps soothe discomfort and provides a sense of relief when your skin is feeling irritated or damaged.

Rest assured, there are no 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 are an adult or a child aged 2 years and 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 the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a physician (doctor). Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product. However, always use it as directed and consult with a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, it's important to remember that it is for external use only and should not come into contact with your eyes. If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and consult a doctor. Additionally, avoid using it on wounds or damaged skin, and do not apply it in large amounts, especially on raw or blistered areas. Always follow the recommended dosage unless directed otherwise by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. It's important to stop using it and consult your doctor if your condition worsens or if symptoms last longer than 7 days. Additionally, if your symptoms improve and then return within a few days, you should also reach out to your doctor. Be cautious not to use large amounts, especially on raw or blistered skin, and do not apply it to wounds or damaged areas.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and guidelines to ensure your safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room. If possible, have the medication packaging with you to help medical professionals understand what you've taken. Remember, it's always better to be safe and get help if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including lidocaine HCl cream. Currently, there is no specific information available about the safety of using this cream during pregnancy, which means that potential risks and benefits have not been clearly established.

Before using lidocaine HCl cream, you should consult with your healthcare provider to discuss any concerns and to ensure that you are making the best choice for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of lidocaine HCL cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that lidocaine HCL cream is excreted in breast milk or that it poses any risk to your infant while you are lactating.

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

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this product without first consulting a physician (a medical doctor).

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 please follow these guidelines carefully.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the packaging before use; do not use the product if the seal is broken, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its integrity.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years of age, it is 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 primary use of this drug?

This drug is used for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a physician.

Are there any warnings I should be aware of?

Yes, this drug is for external use only, and you should avoid contact with eyes. Do not use on wounds or damaged skin.

What should I do if I swallow this product?

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

When should I stop using this drug?

You should stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding the use of this drug during pregnancy.

Can nursing mothers use this drug?

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

How should I store this drug?

Store the drug at room temperature and do not use it if the seal is broken.

Packaging Info

Below are the non-prescription pack sizes of Inkorporated Numbing (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inkorporated Numbing.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations.

There are no teratogenic or nonteratogenic effects 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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a physician. Healthcare professionals are advised to assess the necessity and safety of treatment in this age group before proceeding with any application.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. In the event that the condition worsens or symptoms persist for more than 7 days, the patient should discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, the patient is advised to stop use and seek medical advice. Caution is advised against using this product in large quantities, particularly on raw surfaces or blistered areas, and the recommended daily dosage should not be exceeded unless directed by a physician. This product should not be applied to wounds or damaged skin.

In cases where the product is ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to stop using the product and consult their doctor if the condition worsens or if symptoms persist beyond 7 days. Furthermore, if symptoms improve and then reappear within a short timeframe, it is essential to discontinue use and seek medical guidance.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought.

It is important to note that the product should not be used in large quantities, especially over raw surfaces or blistered areas, and the recommended daily dosage should not be exceeded unless directed by a healthcare professional. Furthermore, the product is contraindicated for use on wounds or damaged skin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Inkorporated Numbing (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Inkorporated Numbing.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product is not recommended, and consultation with a physician is advised.

It is important 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of lidocaine hydrochloride cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering the administration of this medication to pregnant patients. There are no available studies detailing potential risks or fetal impacts associated with lidocaine hydrochloride cream during pregnancy. Therefore, it is recommended that healthcare providers weigh the potential benefits against any unknown risks before prescribing this medication to women of childbearing potential.

Lactation

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

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status. Monitor for any signs of toxicity or adverse reactions.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, intravenous fluids, and monitoring in a controlled environment.

  3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration to limit further absorption of the substance. Gastric lavage may be indicated in certain cases, but only if performed within a suitable timeframe and under appropriate clinical circumstances.

  4. Antidotes: Identify if a specific antidote is available for the substance involved in the overdose. Administer the antidote as per established protocols.

  5. Consultation: Engage with a poison control center or toxicology expert for guidance on management strategies tailored to the specific situation.

  6. Documentation: Ensure thorough documentation of the incident, including the substance involved, estimated dose, time of ingestion, and all interventions performed.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose cases, utilizing established protocols and resources to ensure optimal patient outcomes.

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 that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, the product must not be used if the seal is broken, as this may compromise its safety and efficacy. Proper handling and storage conditions are crucial to ensure the product remains suitable for use.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, use is not advised without consulting a physician.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Inkorporated Numbing, 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 Inkorporated Numbing, 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.