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Tattoonumb

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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
November 12, 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
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M017
NDC root
54723-030
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

You can use this medication for temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage symptoms associated with various conditions. If you're experiencing pain or itching, this drug may provide the relief you need.

Uses

You can use this medication for the temporary relief of pain and itching. It’s designed to help ease discomfort, making it a useful option when you need quick relief from these symptoms.

Rest assured, there are no teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication. This makes it a safer choice for those concerned about potential risks.

Dosage and Administration

To use this medication effectively, start by cleaning and drying the area that needs treatment. You should then apply the medication directly to the affected area. For adults and children aged 12 years and older, you can do this up to 3 to 4 times a day.

If the person needing treatment is a child younger than 12 years old, it’s important to consult a doctor before using the medication. This ensures that the treatment is safe and appropriate for their age.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely.

However, it's always important to consult with your healthcare provider about any medications you are considering, as they can provide personalized advice based on your health history and current medications.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only use it externally and avoid applying it to wounds or damaged skin. If you notice any worsening of your condition, or if symptoms last more than 7 days or return after improvement, stop using the product and consult your doctor. Additionally, keep it away from your eyes, rashes, and mucous membranes, and ensure it is out of reach of children and pets. If swallowed, seek medical help immediately or contact a Poison Control Center.

Please remember not to use this product if you are allergic to any of its ingredients, and always follow the directions provided.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to wounds or damaged skin. It's important to use it as directed and to steer clear of your eyes, rashes, or mucous membranes. If you notice that your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor.

Make sure to keep this product out of reach of children and pets. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately. Always be cautious and prioritize your safety while using this product.

Overdose

It's important to keep this medication out of reach of children and pets. If someone accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but if you suspect that an overdose has occurred, do not hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health. Always prioritize reaching out for professional assistance in these situations.

Pregnancy Use

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

Additionally, if you are pregnant, your healthcare provider may suggest dosage adjustments to ensure your safety and that of your baby. Always prioritize open communication with your healthcare team to make informed decisions about your health during pregnancy.

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 excreted in breast milk or any potential risks to your infant associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

When considering the use of TATTOONUMB (lidocaine hydrochloride cream) for older adults, it's important to note that the drug insert does not provide specific information about dosage adjustments, safety concerns, or special precautions for elderly patients. This means that while the cream may be used, there are no established guidelines tailored specifically for older adults.

If you are caring for an older adult who may need this medication, it’s advisable to consult with a healthcare professional. They can help determine the best approach and ensure that any potential risks are managed appropriately. Always prioritize open communication with healthcare providers to address any concerns regarding medication use in older individuals.

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 plan.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with clean hands or gloves to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically to the affected area, ensuring the skin is clean and dry before use. For adults and children aged 12 and over, you can apply it up to 3 to 4 times a day. If the patient is a child under 12 years old, it's best to consult a doctor before use.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching.

How should adults and children over 12 use this product?

Clean and dry the affected area, then apply to the affected area no more than 3 to 4 times daily.

What should children 12 years of age or younger do before using this product?

Children 12 years of age or younger should ask a doctor before use.

Are there any contraindications for using this product?

There are no specific contraindications listed, but it should not be used on wounds or damaged skin.

What precautions should I take when using this product?

Use only as directed, avoid contact with eyes and mucous membranes, and keep out of reach of children and pets.

Is this product safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for pregnant women due to potential risks.

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What should I do if this product is swallowed?

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

Are there any known drug interactions with this product?

No drug interactions information is provided.

How should I store this product?

Protect this product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Tattoonumb.
Details

Drug Information (PDF)

This file contains official product information for Tattoonumb, 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.

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

Dosage and Administration

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. The product is to be applied to the affected area no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin, nor should it be used in large quantities. Individuals with known allergies to any of the ingredients in this product should refrain from use.

When utilizing this product, it is essential to adhere strictly to the directions provided. Care should be taken to avoid contact with the eyes, rashes, or mucous membranes, as such contact may lead to adverse effects.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

To ensure safety, this product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to wounds or damaged skin. It is crucial to avoid using the product in large quantities and to refrain from use if there is a known allergy to any of its ingredients.

While using this product, patients must adhere strictly to the directions provided. Contact with the eyes, rashes, or mucous membranes should be avoided to prevent irritation. If a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Tattoonumb.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment in this age group, as specific dosing and safety considerations may apply.

Geriatric Use

There is no specific information regarding the use of TATTOONUMB (lidocaine hydrochloride cream) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

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 fetal outcomes; therefore, it is essential for pregnant patients to consult a healthcare provider before use.

Dosage adjustments may be necessary for individuals who are pregnant, and medical advice should be sought to determine the appropriate course of action. Pregnant women are advised to discuss the use of this product with their healthcare provider to carefully weigh the potential benefits against the associated risks.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children and pets to prevent accidental ingestion. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is essential to follow established protocols for the specific substance involved in the overdosage 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, itching, and hives; as well as systemic reactions such as dizziness, drowsiness, and confusion.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the affected area should be cleaned and dried before applying the medication, with a maximum frequency of 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

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 Tattoonumb, 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 Tattoonumb, 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.