ADD CONDITION

items per page

Dologesic Roll-on

Last content change checked dailysee data sync status

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)
Marketed in the U.S.
Since 2018
Label revision date
December 31, 2025
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
Marketed in the U.S.
Since 2018
Label revision date
December 31, 2025
Manufacturer
Llorens Pharmaceutical International Division, Inc.
Registration number
M017
NDC root
54859-513

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

Dologesic Roll-On is a topical medication designed to temporarily relieve minor pains. It is applied directly to the skin over the area of discomfort, providing targeted relief. This product is suitable for those seeking a convenient way to manage minor aches and pains in their daily lives.

Uses

You can use this medication to temporarily relieve minor pains. It’s designed to help ease discomfort, making it a useful option when you’re dealing with everyday aches. Rest assured, there are no concerns about teratogenic effects (which means it doesn’t cause birth defects) associated with this medication.

Dosage and Administration

You can use this medication if you are an adult or a child over 12 years old. To apply it, generously spread the medication on the affected area as needed. You can do this every 6 to 8 hours, but make sure not to apply it more than three times in a 24-hour period.

Please note that this medication is not suitable for children under 12 years of age, so ensure it is kept out of their reach. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult your doctor if your condition worsens, if symptoms last longer than seven days, or if they improve and then return shortly after.

Additionally, this product is for external use only and should not be applied to large areas of the body, on broken or irritated skin, or on puncture wounds. Avoid contact with your eyes, and do not use heat or bandages on the treated area. Always follow the directions on the label carefully.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or swollen skin. It should not be used on puncture wounds, and you should not use it for more than one week without consulting your doctor. Always follow the directions on the label carefully, and be sure to keep it away from your eyes. Additionally, do not cover the treated area with bandages or apply heat, such as heating pads.

If your condition worsens, or if your symptoms last longer than seven days or return after clearing up, stop using the product and contact your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. 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 breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding any medications you may consider while nursing.

Pediatric Use

This medication is not recommended for children under 12 years of age. If your child is 12 years or older, you can apply it generously to the affected area as needed every 6 to 8 hours. However, be sure not to exceed three applications in a 24-hour period to ensure their safety. Always follow these guidelines to help protect your child's health.

Geriatric Use

While there is no specific information about the use of Dologesic Roll-On (lidocaine hcl liquid) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this product. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions that may be present. Always prioritize safety and seek professional advice when introducing new medications.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication generously to the affected area as needed, but do not exceed three applications within a 24-hour period. If you are pregnant or breastfeeding, it's important to consult your doctor before using this product. Additionally, keep it out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Dologesic Roll-On used for?

Dologesic Roll-On is used to temporarily relieve minor pains.

Who can use Dologesic Roll-On?

It is intended for adults and children over 12 years of age. It should not be used in children under 12.

How should I apply Dologesic Roll-On?

Apply generously to the affected area as needed every 6-8 hours, not exceeding 3 applications in a 24-hour period.

Are there any warnings for using Dologesic Roll-On?

Yes, it is for external use only and should not be used on large areas, cut or irritated skin, or puncture wounds. Do not use for more than one week without consulting a doctor.

What should I do if I swallow Dologesic Roll-On?

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

Can I use Dologesic Roll-On if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a doctor before using Dologesic Roll-On.

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

Stop using Dologesic Roll-On and ask your doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store Dologesic Roll-On?

Store Dologesic Roll-On at room temperature, protect it from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Dologesic Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Dologesic Roll-on, 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 minor pains.

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

Dosage and Administration

Adults and children over 12 years of age should apply the medication generously to the affected area as needed. Applications may be made every 6 to 8 hours; however, the total number of applications must not exceed 3 in a 24-hour period. This medication is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product should not be applied to large areas of the body, nor should it be used on cut, irritated, or swollen skin. It is contraindicated for application on puncture wounds. The product should not be used for more than one week without consulting a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Users must read and follow all directions and warnings indicated on the label. Care should be taken to avoid contact with the eyes. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads.

Patients are advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven 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 contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. Additionally, patients are advised not to use the product for more than one week without consulting a healthcare professional.

During the use of this product, it is crucial to adhere strictly to the provided directions and warnings. Patients should avoid contact with the eyes and refrain from bandaging or applying local heat, such as heating pads, to the area of application.

Patients are instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven 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 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 Dologesic Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dologesic Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended application is to apply generously to the affected area as needed every 6-8 hours, with a maximum of 3 applications within a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to avoid potential overuse.

Geriatric Use

There is no specific information regarding the use of Dologesic Roll-On (lidocaine hcl liquid) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the variability in drug response and the potential for increased sensitivity to medications in older adults.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the urgency of this situation to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply the medication generously to the affected area as needed every 6-8 hours, ensuring that the total number of applications does not exceed three in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. Additionally, it is important to keep the medication out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Dologesic 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 Dologesic 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

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.