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Painless Tattoo Numbing

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 2024
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M017
NDC root
54723-019
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 the 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 is designed to help alleviate discomfort, making it easier for you to manage your symptoms.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to effects that do not cause harm during pregnancy) associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. It's important to apply it only to the affected area of your skin, and avoid spraying it on your face. For adults and children aged 12 years and older, first clean and dry the area you want to treat. You can then apply the medication to that area up to 3 to 4 times a day.

If you are considering this medication for a child younger than 12 years old, it's best to consult with a doctor first to ensure it's safe and appropriate for them.

What to Avoid

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 particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety warnings. This product is for external use only and is flammable, so avoid using it near heat, flames, or while smoking. Do not apply it to wounds or damaged skin, and make sure you are not allergic to any of its ingredients. If you notice that your condition worsens, or if symptoms last more than 7 days or return after improvement, stop using the product and consult your doctor.

Additionally, keep this product out of reach of children and pets. If swallowed, seek medical help or contact a Poison Control Center immediately. Always use the product as directed, and avoid contact with your face and eyes. Store it properly, away from high temperatures, and do not puncture or incinerate the container.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin, and do not use it in large amounts. It's important to keep it away from heat, flames, and smoking areas, as it is flammable. When using the product, follow the directions carefully, and keep it away from your face to prevent inhalation. Make sure to avoid contact with your eyes and store it at temperatures below 120°F. Never puncture or burn the container.

If your condition worsens, or if your symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. Always keep this product out of reach of children and pets. If swallowed, seek medical help or contact a Poison Control Center immediately.

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 remember that it's better to be cautious and seek assistance if you have any concerns.

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. Its use is generally not recommended because it may pose potential risks to your developing baby. 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 to ensure safety. Always prioritize open communication with your healthcare provider about your pregnancy and any medications you are considering.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is 12 years old or younger, it's important to consult a doctor before using this medication. For those aged 12 and older, you should clean and dry the affected area before applying the medication. It can be used on the affected area up to 3 to 4 times a day.

Always keep this medication out of reach of children and pets. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

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 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 safety and effectiveness of your product, store it in a cool, dry place where temperatures do not exceed 120°F. It's important to protect it from excessive heat and direct sunlight, as these conditions can damage the product. Always keep it out of reach of children and pets to prevent accidental exposure.

When handling the product, avoid puncturing or incinerating it, as this can pose safety risks. By following these simple guidelines, you can help maintain the integrity of the product and ensure safe usage.

Additional Information

You should apply this medication topically to the clean and dry affected area. For adults and children aged 12 years and older, you can use 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 I apply this drug?

For adults and children 12 years and older, clean and dry the affected area, then apply to the area no more than 3 to 4 times daily. For children under 12, consult a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only, is flammable, and should not be used on wounds or damaged skin. Avoid contact with eyes and keep away from heat and flame.

What should I do if my condition worsens?

Stop using the product and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is advised to consult a healthcare provider before use.

What precautions should I take when using this drug?

Keep this product out of reach of children and pets, do not store above 120°F, and avoid puncturing or incinerating the container.

Can I use this drug if I am nursing?

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

Packaging Info

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

Packaging configurations for Painless Tattoo Numbing.
Details

Drug Information (PDF)

This file contains official product information for Painless Tattoo 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.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use. The product is intended for external use only and should not be sprayed on the face.

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

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

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

This product is intended for external use only. It is imperative to recognize that the formulation is flammable; therefore, it should not be used near heat sources, open flames, or while smoking.

Caution is advised against applying the product to wounds or damaged skin, using it in excessive quantities, or if there is a known allergy to any of its ingredients. Users must adhere strictly to the directions provided for use. It is essential to keep the product away from the face to prevent inhalation and to avoid contact with the eyes. Storage should be maintained at temperatures not exceeding 120°F, and the product must not be punctured or incinerated.

In the event that the condition worsens, or if symptoms persist beyond 7 days or resolve only to recur within a few days, it is crucial to discontinue use and consult a healthcare professional.

This product should be kept out of reach of children and pets. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and is classified as flammable; therefore, it should not be used near heat, flame, or while smoking. The product should not be applied to wounds or damaged skin, in large quantities, or by individuals who are allergic to any of its ingredients.

When using this product, it is crucial to follow the directions provided. Users should keep the product away from the face to avoid inhalation and should avoid contact with the eyes. Additionally, it should not be stored at temperatures exceeding 120°F, and users must refrain from puncturing or incinerating the container.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also essential to keep the product 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 should be made.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Painless Tattoo Numbing (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Painless Tattoo Numbing.
Details

Pediatric Use

Pediatric patients 12 years of age and younger should consult a healthcare professional before use. For patients aged 12 years and older, the recommended application involves cleaning and drying the affected area, followed by application to the affected area no more than 3 to 4 times daily.

It is essential to keep the product 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 advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is contraindicated in pregnancy 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 individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use this product only if clearly needed and after 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 are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 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 should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay for guidance on appropriate management.

Prompt action is crucial in cases of overdosage to mitigate potential health risks. Symptoms of overdosage may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage any adverse effects that may arise.

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 question.

Postmarketing Experience

Reports of adverse reactions associated with the use of lidocaine hydrochloride have been received through voluntary reporting and surveillance programs. These reactions include allergic reactions and skin irritation. Additionally, systemic toxicity has been noted, which may manifest as seizures, cardiovascular events, or respiratory depression. Other unspecified adverse events have also been reported in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

This product is supplied in configurations that ensure optimal handling and storage. It is essential to store the product at temperatures not exceeding 120°F. Care should be taken to protect the product from excessive heat and direct sunlight to maintain its integrity.

To ensure safety, the product must be kept out of reach of children and pets. Additionally, it is crucial not to puncture or incinerate the container, as this may compromise the product's safety and efficacy.

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, which may be used up to 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 Painless Tattoo 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 Painless Tattoo 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

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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.