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Recovery Numb

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 0.04 g/1 g
Other brand names
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 2017
Label revision date
June 27, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.04 g/1 g
Other brand names
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 2017
Label revision date
June 27, 2017
Manufacturer
Sambria Pharmaceuticals
Registration number
part348
NDC root
54723-528
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 minor skin irritations. Whether you're dealing with a small rash, insect bite, or other minor skin issues, this drug can help soothe your discomfort and improve your overall comfort.

It's important to remember that this medication is intended for short-term use, focusing on alleviating symptoms rather than treating underlying conditions. If you have any concerns about your skin irritation or if symptoms persist, consider consulting a healthcare professional for further advice.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. It’s designed to help soothe discomfort and make your skin feel better.

Rest assured, there are no known 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

You can use this medication for yourself or your child if they are two years old or older. Simply apply it to the affected area of the skin, but make sure to do this no more than three to four times a day. If your child is under two years old, it's important to consult a physician (doctor) before using the medication to ensure it's safe for them. Always follow these guidelines to help manage the condition effectively.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

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. Avoid applying it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. It's important to keep this product out of reach of children. If someone accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then come back within a few days. Your health and safety are the top priority, so please take these precautions seriously.

Overdose

Using this medication in large amounts, especially on raw or blistered skin, can lead to serious issues. It's important to be cautious and avoid applying more than recommended.

If you suspect an overdose, look for signs such as unusual skin reactions or increased irritation. In such cases, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your usage.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride cream during pregnancy has not been established. Its use is generally not recommended because there may be potential risks to your developing baby. If you are considering using this cream, it’s crucial to consult your healthcare provider for personalized advice.

Additionally, if you are prescribed this medication while pregnant, your doctor may need to adjust the dosage to ensure safety. Always seek guidance from your physician to make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use lidocaine hydrochloride cream without specific warnings or recommendations against it. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your nursing infant. As always, if you have concerns or questions about using any medication while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than three or four times a day. However, if your child is under two years old, it’s important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

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 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 consult with your healthcare provider about your individual situation, as they 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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment 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

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching due to minor skin irritation.

Who can use this drug?

It is intended for adults and children two years or older. For children under 2 years of age, you should consult a physician.

How often can I apply this drug?

You can apply it to the affected area not more than 3 or 4 times daily.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but it is not recommended during pregnancy due to potential risks to the fetus.

What should I do if my condition worsens?

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

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and there may be risks associated with its use; consult a healthcare provider for advice.

What precautions should I take when using this drug?

For external use only, avoid contact with eyes, and do not use in large quantities, particularly over raw surfaces or blistered areas.

What should I do if the product is swallowed?

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

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding its use in nursing mothers mentioned.

Packaging Info

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

Packaging configurations for Recovery Numb.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. It is packaged in a tube and features a die cut design.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritation.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is essential to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriateness of treatment and to receive specific dosing recommendations.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially over raw surfaces or blistered areas, to prevent adverse effects.

General precautions must be observed to ensure safety. The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to stop using the product and seek medical advice.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept away from the eyes to prevent irritation.

In clinical practice, it is advised not to use the product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Recovery Numb.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is recommended to consult a physician prior to use.

Geriatric Use

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

Pregnancy

Safety during pregnancy has not been established for lidocaine hydrochloride cream. Use of this medication is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine hydrochloride cream during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage adjustments may be necessary for pregnant individuals, and it is advisable to consult a physician for guidance on appropriate dosing in this population.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine hydrochloride cream in lactating mothers. Additionally, there is no information available about the potential for excretion of lidocaine 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 population 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 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 overdosage, it is critical to adhere to specific guidelines to mitigate potential adverse effects.

Recommended Actions Healthcare professionals should exercise caution and avoid the application of the product in large quantities, especially on raw surfaces or blistered areas. This precaution is essential to prevent exacerbation of symptoms and to ensure patient safety.

Potential Symptoms While specific symptoms of overdosage are not detailed, the emphasis on avoiding large quantities suggests that excessive application may lead to localized irritation or other adverse reactions, particularly in sensitive areas of the skin.

Management Procedures In cases of suspected overdosage, it is advisable to assess the affected area and monitor the patient for any signs of irritation or discomfort. If symptoms arise, appropriate symptomatic treatment should be initiated. Additionally, healthcare professionals should consider consulting a poison control center or relevant medical authority for further guidance on management strategies tailored to the specific situation.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor 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 important for patients to be aware of these guidelines to ensure safe and effective use of the product.

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.

Storage conditions should be monitored to avoid exposure to high temperatures, which may compromise the product's quality. Proper storage in a cool, dry place is recommended to ensure optimal preservation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Recovery Numb, 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 Recovery Numb, 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.