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Painless Tattoo 1

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Active ingredient
Benzocaine 20 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
November 12, 2025
Active ingredient
Benzocaine 20 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M017
NDC root
54723-015

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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) associated with this medication, so it’s considered safe in that regard.

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 child receives the appropriate care and dosage. Always follow these guidelines to help ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of 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 you.

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 seven days, or improve and then return shortly after, stop using the product and consult your doctor.

Additionally, be cautious to keep the product away from your eyes, rashes, and mucous membranes. If you have allergies to any of the ingredients, do not use it. Always keep it out of reach of children and pets, and if swallowed, seek medical help immediately or contact a Poison Control Center.

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 keep it away from your eyes, rashes, and 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 check the ingredient list to ensure you are not allergic to any components before use.

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, acting quickly is crucial. Always prioritize safety and don't hesitate to reach out for professional assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is generally not recommended for use during pregnancy.

Before using any products containing benzocaine, you should consult your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's best to seek professional advice.

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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, you should clean and dry the affected area before applying the medication. You can apply it to the affected area no more than 3 to 4 times a day.

If your child is 12 years old or younger, it's essential to consult a doctor before use. This ensures that the treatment is safe and appropriate for their age and condition. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When it comes to using Painless Tattoo 1 (benzocaine cream) for older adults, there is no specific information available about dosage adjustments or safety concerns. This means that the drug insert does not provide special precautions tailored for elderly patients.

If you are considering this product for yourself or a loved one, it’s important to consult with a healthcare professional. They can help determine if this cream is appropriate and safe based on individual health needs and any other medications being taken. Always prioritize safety and seek guidance when using new treatments.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

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, and your healthcare team is there to support 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

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 care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

For adults and children aged 12 and over, you should clean and dry the affected area before applying the medication. It can be applied to the affected area no more than 3 to 4 times a day. If the patient is a child under 12 years old, it's important 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 under 12 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.

What should I do if my condition worsens or symptoms persist?

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

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

Can nursing mothers use this product?

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

What should I do if I accidentally swallow this product?

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

Packaging Info

Below are the non-prescription pack sizes of Painless Tattoo 1 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Painless Tattoo 1.
Details

Drug Information (PDF)

This file contains official product information for Painless Tattoo 1, 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 specified 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

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 not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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 product's ingredients should refrain from use.

Users must adhere strictly to the directions provided. Care should be taken to avoid contact with the eyes, rashes, or mucous membranes during application. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is essential to discontinue use and consult a healthcare professional.

To ensure safety, this product should be kept out of reach of children and pets. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The 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 adverse effects. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

Additionally, 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 recommended.

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 Painless Tattoo 1 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Painless Tattoo 1.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area, ensuring the area is clean and dry, up to 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of Painless Tattoo 1 (benzocaine 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 outcomes in this population.

Pregnancy

The safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using benzocaine to discuss potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information 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 considered as part of standard clinical practice.

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 are advised to contact a Poison Control Center without delay for guidance on appropriate management.

Prompt intervention is crucial in managing potential overdosage scenarios. 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.

In summary, vigilance in preventing access to the product and swift action in the case of ingestion are essential components of effective overdosage management.

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 manifestations such as rash, itching, and hives.

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 safeguarding the medication in a secure location, ensuring that children cannot access it. This precaution helps to minimize the risk of potential harm associated with unintentional exposure to the medication.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

For patients 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 before use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Painless Tattoo 1, 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 1, 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.

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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.