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Shield and Heal Medicated Lip Balm

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This product has been discontinued

Active ingredient
Menthol 10 mg/1 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
April 27, 2023
Active ingredient
Menthol 10 mg/1 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
April 27, 2023
Manufacturer
Shield and Heal Inc.
Registration number
part348
NDC root
81470-001

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Drug Overview

You may find this medication helpful for the temporary relief of pain and itching associated with fever blisters and cold sores. It is designed to provide comfort during these uncomfortable outbreaks, allowing you to manage symptoms more effectively. If you experience fever blisters or cold sores, this medication can be a supportive option to consider for alleviating your discomfort.

Uses

If you're dealing with the discomfort of fever blisters and cold sores, this medication can help provide temporary relief from the pain and itching associated with these conditions. It's designed to ease your symptoms, allowing you to feel more comfortable while you recover.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

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 immediately or contact a Poison Control Center. Additionally, be careful to avoid contact with your eyes, as this can lead to irritation or other issues. Always prioritize safety when using any medication.

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 if your condition worsens or symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor.

Keep this product out of reach of children. If it is 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 any areas that may come into contact with your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult your doctor.

In the event that the product is swallowed, seek medical help immediately or contact a Poison Control Center for assistance. Your safety is a priority, so please take these precautions seriously.

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 seek assistance if you suspect an overdose.

Pregnancy Use

There is no specific information available regarding the use of SHIELD AND HEAL MEDICATED LIP BALM during pregnancy. If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products. They can help you understand any potential risks and ensure that you make safe choices for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the benefits and risks to ensure the safety of both you and your baby.

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 the medication 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 using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

While there is no specific information about the use of SHIELD AND HEAL MEDICATED LIP BALM in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before using this product, especially if you have any underlying health conditions or are taking other medications.

As a caregiver or an older adult, being mindful of how new products may interact with your health is important. Always prioritize safety and seek guidance if you have any questions or concerns.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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, and there are no special monitoring or precautions outlined for patients like you.

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 provide guidance 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. In this case, there are no known drug interactions or laboratory test interactions reported. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from excessive heat. This helps maintain its effectiveness and safety for use.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain and itching associated with fever blisters and cold sores.

How often can adults and children 2 years of age and older use this drug?

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

What should I do if my child is under 2 years of age?

If your child is under 2 years of age, you should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are specified for this drug.

What precautions should I take when using this product?

This product is for external use only. Avoid contact with eyes, and if the condition worsens or symptoms persist for more than 7 days, discontinue use and consult a doctor.

What should I do if the product is swallowed?

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

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided.

How should I store this drug?

Store at room temperature and avoid excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Shield and Heal Medicated Lip Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shield and Heal Medicated Lip Balm.
Details

Drug Information (PDF)

This file contains official product information for Shield and Heal Medicated Lip Balm, 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 fever blisters and cold sores.

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 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 should be sought or contact with a Poison Control Center is advised.

  • Contact with eyes should be avoided to prevent irritation or injury.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to discontinue use and seek medical consultation if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to avoid contact with the eyes. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. 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.

While using this product, patients should take care to avoid contact with the eyes.

Additionally, it is important to keep this 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 currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Shield and Heal Medicated Lip Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shield and Heal Medicated Lip Balm.
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

Elderly patients may not have specific information regarding the use of SHIELD AND HEAL MEDICATED LIP BALM, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when recommending this product to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or unusual reactions when using this product. Further, consideration should be given to the overall health status and concurrent medications of geriatric patients to ensure safe and effective use.

Pregnancy

There is no specific information regarding the use of SHIELD AND HEAL MEDICATED LIP BALM during pregnancy. As such, the potential risks and effects on fetal outcomes remain undetermined. Healthcare professionals are advised to exercise caution when recommending this product to pregnant patients. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

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 data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

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

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should emphasize the need to avoid contact with the eyes. Patients should be informed about the potential risks associated with eye exposure and encouraged to take precautions to prevent such contact.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent any potential degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Shield and Heal Medicated Lip Balm, 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 Shield and Heal Medicated Lip Balm, 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.

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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.