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Caring Mill Lidocaine Aloe Gel Burn and Pain Relief

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Active ingredient
Lidocaine Hydrochloride 5 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 mg/1 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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 12, 2024
Manufacturer
FSA Store Inc.
Registration number
M017
NDC root
81522-953
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 burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. It works by soothing the affected area, helping you feel more comfortable while your skin heals.

If you're dealing with any of these minor skin issues, this product can be a helpful option to alleviate discomfort and promote healing. Always remember to follow the instructions for use to ensure the best results.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, or other minor skin irritations. It helps soothe discomfort and promotes a sense of relief, allowing you to feel more comfortable while your skin heals.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, you should apply it to the affected area no more than 3 to 4 times a day. This helps ensure that you get the best results while minimizing any potential side effects.

For children under 2 years of age, it's important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always follow these instructions carefully to ensure safe and effective use.

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. 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 symptoms last more than 7 days or return after clearing up, stop using the product and consult a doctor.

Keep this product out of reach of children. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor.

Be cautious not to use large amounts, especially on raw or blistered skin. Always keep this product out of reach of children. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can make a significant difference in managing the situation effectively.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided. If you notice anything concerning, don’t hesitate to reach out for professional assistance. Remember, your safety is the top priority, so don’t wait to get help if you suspect an overdose.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but always consult your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

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 monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures between 68°F to 77°F (20°C to 25°C). This temperature range helps maintain its effectiveness and safety.

When handling the product, be cautious as it may stain some fabrics or surfaces. Always use care to avoid contact with materials that could be damaged. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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 my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, discontinue use and consult a doctor.

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy.

Can nursing mothers use this drug?

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

How should I store this drug?

Store the drug between 68°F to 77°F (20°C to 25°C).

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 product.

Packaging Info

Below are the non-prescription pack sizes of Caring Mill Lidocaine Aloe Gel Burn and Pain Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Caring Mill Lidocaine Aloe Gel Burn and Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Caring Mill Lidocaine Aloe Gel Burn and Pain Relief, 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 associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

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 application is to the affected area not 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 patients who may apply the product in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects. No other contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

In cases where 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 imperative to discontinue use of the product and consult a healthcare provider for further evaluation and management.

Caution is advised against the application of this product in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

It is essential to keep this product 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.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional.

The product should not be used in large quantities, especially over raw surfaces or blistered areas. Additionally, it is important to keep the product out of reach of children. If the product is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Caring Mill Lidocaine Aloe Gel Burn and Pain Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Caring Mill Lidocaine Aloe Gel Burn and Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients and consider alternative therapies where appropriate.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual case. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 insert text.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product in a controlled environment, maintaining a temperature range between 68°F to 77°F (20°C to 25°C). Care should be taken to avoid contact with fabrics or surfaces, as the product may cause staining. Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Caring Mill Lidocaine Aloe Gel Burn and Pain Relief, 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 Caring Mill Lidocaine Aloe Gel Burn and Pain Relief, 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.