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Tattoo Numbing Cream Co

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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
54723-023
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 is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, so it is 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 treatment is safe and appropriate for their age.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

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 experience any worsening of your condition or if symptoms persist for more than seven days, it's best to stop using the product and consult your doctor. Additionally, if you accidentally swallow the product, seek medical help immediately.

Be cautious if you have allergies to any of the ingredients, and avoid contact with your eyes, rashes, or mucous membranes. Always keep the product out of reach of children and pets to ensure their safety.

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. If you are allergic to any of the ingredients, do not use this product. When applying, follow the directions carefully and steer clear of your eyes, rashes, or mucous membranes.

If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor. Keep this product out of reach of children and pets. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a healthcare professional.

Pregnancy Use

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

Additionally, if you are pregnant, your healthcare provider may suggest dosage adjustments to ensure your safety and that of your baby. Always have an open conversation with your healthcare provider before using this product to make informed decisions about your health and your 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. 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 using lidocaine hydrochloride cream, you can feel reassured that there are no specific concerns or dosage adjustments needed for older adults. This means that the cream is generally considered safe for use without special precautions related to age. However, as with any medication, it's always a good idea to consult with a healthcare provider to ensure it’s appropriate for your individual health needs.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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

Additional Information

You should apply this medication topically to clean and dry affected areas. For adults and children aged 12 and over, use it no more than 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 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 do not use 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 I accidentally swallow this product?

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

Is this product safe to use during pregnancy?

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

What should nursing mothers know about this product?

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

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.

Packaging Info

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

Packaging configurations for Tattoo Numbing Cream Co.
Details

Drug Information (PDF)

This file contains official product information for Tattoo Numbing Cream Co, 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

For adults and children aged 12 years and over, 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 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 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 if symptoms clear up 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 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 Tattoo Numbing Cream Co (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tattoo Numbing Cream Co.
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

Elderly patients may use lidocaine hydrochloride cream without specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information. However, as with all medications, it is advisable for healthcare providers to monitor geriatric patients for any potential adverse effects or unusual responses to treatment, given the variability in drug metabolism and sensitivity that can occur with aging. Regular assessment of the patient's overall health status and any concurrent medications is recommended to ensure safe and effective use of the cream in this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks associated with its use. There may be risks to the fetus, and it is advised that pregnant patients consult their healthcare provider for personalized advice regarding the use of this product.

Dosage adjustments may be necessary for pregnant patients; therefore, medical guidance should be sought to determine appropriate dosing. Pregnant women are encouraged to discuss the use of this product with their healthcare provider prior to application to ensure safety for both the mother and the developing fetus.

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 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 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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

No postmarketing experience details are available in the insert text.

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 for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from areas where children may have access.

Storage and Handling

This product should be protected from excessive heat and direct sunlight to maintain its integrity and efficacy. It is essential to store the product in a cool, dry place, away from sources of heat and light. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

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 Tattoo Numbing Cream Co, 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 Tattoo Numbing Cream Co, 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.