Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Theraseal

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 1.7 g/170.1 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 2012
Label revision date
October 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 1.7 g/170.1 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 2012
Label revision date
October 17, 2024
Manufacturer
Bausch Health US, LLC
Registration number
M014
NDC root
0187-1660
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

TheraSeal® is a skin protectant designed to help prevent and temporarily protect chafed, chapped, cracked, and dry skin. It is particularly effective in safeguarding damaged hands from harmful irritants, making it a useful option for those who frequently expose their skin to harsh conditions. This patented formulation provides a barrier that helps maintain skin integrity and comfort.

Uses

This product is designed to help prevent and provide temporary protection for skin that is chafed, chapped, cracked, or dry. If you often experience these skin issues, using this product can offer relief and support for your skin's health.

Additionally, it protects your hands from harmful irritants, making it a great choice for anyone who frequently comes into contact with substances that can cause skin irritation. By using this product, you can help keep your skin in better condition and reduce discomfort.

Dosage and Administration

You should apply the medication liberally, meaning you can use a generous amount each time. It's important to do this as often as necessary, depending on your needs. This approach ensures that you get the most benefit from the treatment. Always listen to your body and adjust the frequency of application as required.

What to Avoid

It's important to use this product safely and effectively. Remember, it is for external use only, so do not apply it to your eyes or any deep or puncture wounds, infections, or lacerations. Taking these precautions will help ensure your safety while using the product. If you have any questions or concerns about its use, please consult a healthcare professional.

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 to deep wounds, infections, or cuts. If your condition worsens or does not improve within a week, please consult a physician.

Additionally, keep this product out of reach of children to ensure their safety.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. It's important not to use it on deep wounds, puncture wounds, infections, or lacerations. If your condition worsens or does not improve within 7 days, you should consult a physician.

Make sure to keep this product out of reach of children to prevent accidental ingestion or misuse. Always prioritize safety when using any medication or treatment.

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, or if you are unsure, 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 be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

Currently, there is no information available about the use of TheraSeal (dimethicone cream) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Additionally, there is no information suggesting that this product is passed into breast milk or poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about the use of TheraSeal (dimethicone cream) in older adults, it’s always important to approach any new treatment with caution. If you or a loved one is considering using this cream, it’s a good idea to consult with a healthcare provider, especially if there are existing health concerns or other medications involved.

Since the drug insert does not mention any dosage adjustments or safety precautions for elderly patients, your healthcare provider can help determine the best approach for your individual needs. Always prioritize open communication with your doctor to ensure safe and effective use of any medication or treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

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 dosing may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help monitor your liver function and ensure that any medications you take are safe and effective for you. Always keep your doctor informed about your liver health to receive the best care possible.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use the contents within a specified time frame, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is TheraSeal® used for?

TheraSeal® helps prevent and temporarily protect chafed, chapped, cracked, and dry skin, while also protecting damaged hands from harmful irritants.

How should I apply TheraSeal®?

You should apply TheraSeal® liberally as often as necessary.

Are there any precautions I should take when using TheraSeal®?

Yes, avoid contact with eyes and do not apply it over deep or puncture wounds, infections, or lacerations. If your condition worsens or does not improve within 7 days, consult a physician.

Is TheraSeal® safe for children?

You should keep TheraSeal® out of reach of children.

Can I use TheraSeal® during pregnancy or while nursing?

There is no specific information regarding the use of TheraSeal® during pregnancy or lactation, so consult your healthcare provider for advice.

How should I store TheraSeal®?

Store TheraSeal® at room temperature, protect it from light, and keep the tube tightly closed when not in use.

Are there any known drug interactions with TheraSeal®?

No drug interactions were found in the provided information.

Packaging Info

Below are the non-prescription pack sizes of Theraseal (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraseal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraSeal® Hand Protection is a skin protectant designed to safeguard hands from harmful irritants. It features a patented formulation that enhances its protective capabilities. The product is available in a net weight of 6 ounces.

Uses and Indications

This drug is indicated for the prevention and temporary protection of chafed, chapped, cracked, and dry skin. It is specifically formulated to protect hands from harmful irritants, providing a barrier that helps maintain skin integrity in challenging environments.

Dosage and Administration

Healthcare professionals are advised to apply the medication liberally to the affected area as often as necessary. It is important to assess the patient's condition regularly to determine the frequency of application required for optimal therapeutic effect.

Contraindications

The product is contraindicated for external use only. It should not come into contact with the eyes. Additionally, application is contraindicated over deep or puncture wounds, infections, or lacerations due to the risk of exacerbating these conditions.

Warnings and Precautions

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

It is crucial that this product not be applied to deep or puncture wounds, infections, or lacerations. If the patient's condition worsens or does not show improvement within 7 days of use, a consultation with a physician is recommended to reassess the treatment plan.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes while using this product. Additionally, it should not be applied over deep or puncture wounds, infections, or lacerations. If the condition worsens or does not improve within 7 days, patients are advised to consult a physician.

In terms of safety, it is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Theraseal (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraseal.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is warranted when considering its use in this demographic.

Geriatric Use

There is no specific information regarding the use of TheraSeal (dimethicone cream) 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 monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any concurrent medications of geriatric patients to ensure safe and effective use of TheraSeal.

Pregnancy

There is currently no information available regarding the use of TheraSeal (dimethicone cream) during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered in the absence of established safety data.

Lactation

There are no specific warnings or recommendations regarding the use of this product in 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for effective treatment 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 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 this product out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize that the product is intended for external use only, and patients should be instructed to avoid contact with the eyes during application.

Additionally, healthcare providers should inform patients that the product should not be applied over deep or puncture wounds, infections, or lacerations. Patients should be counseled to monitor their condition closely; if it worsens or does not improve within 7 days, they should seek medical advice from a physician.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within a specified time frame.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Theraseal, 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 Theraseal, 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.