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Odorless Analgesic Roll-on

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
July 11, 2018
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
July 11, 2018
Manufacturer
Meijer
Registration number
part348
NDC root
41250-790

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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 associated with various conditions, 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 noted with this medication, ensuring its safety in those aspects.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. If your child is under 2 years of age, it’s important to consult a doctor before using this medication.

Make sure to follow these guidelines closely to ensure the best results. Remember, applying the medication too frequently may not provide additional benefits and could lead to irritation. Always wash your hands before and after applying the medication to keep the area clean and avoid spreading any infection.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only, so avoid contact with your eyes and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more 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 use it as directed. Avoid getting it in your eyes, and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last longer than 7 days or come back after improving, stop using the product and consult your doctor.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or precautions regarding the use of this product during pregnancy. The information available does not indicate whether the product is contraindicated (not recommended) for pregnant individuals or if there are any risks to the developing fetus. Additionally, there are no dosage modifications or special precautions outlined for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

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 children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before use to ensure safety and proper care. Always prioritize your child's health by following these recommendations closely.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

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.

What is the recommended dosage for adults and children over 2 years?

Adults and children 2 years of age and older should apply to the affected area not more than 3 to 4 times daily.

What should I do if I have a child under 2 years?

Consult a doctor before using this product on children under 2 years of age.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this product?

Use only as directed, avoid contact with eyes, and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if I accidentally swallow this product?

Get medical help or contact a Poison Control Center immediately if swallowed.

Is this drug safe to use during pregnancy?

There are no specific warnings or precautions regarding the use of this product during pregnancy.

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 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.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Odorless Analgesic Roll-on (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Odorless Analgesic Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Odorless Analgesic Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

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 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion.

  • In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product in large quantities, especially on raw surfaces or blistered areas.

Patients should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

It is imperative that patients are made aware of the necessity to stop using the product and to reach out to their healthcare provider under the aforementioned circumstances to ensure appropriate management and care.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed and to avoid contact with the eyes. Additionally, patients should refrain from using large quantities, especially over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. These warnings are essential to ensure the safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Odorless Analgesic Roll-on (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Odorless Analgesic Roll-on.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The available data does not indicate any specific warnings or precautions regarding the use of this product during pregnancy. There is no information suggesting that the product is contraindicated in pregnant patients, nor are there any identified risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential and pregnant patients regarding the use of this product.

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

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any symptoms observed, is crucial for effective management and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of serious harm.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Odorless Analgesic Roll-on, 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 Odorless Analgesic Roll-on, 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.