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Fixmyskin Healing Balm Unflavored

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Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
December 31, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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 2011
Label revision date
December 31, 2024
Manufacturer
Lovely Skin, Inc.
Registration number
M017
NDC root
76314-003
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

FixMySkin Healing Balm Unflavored is a specially formulated balm designed to help soothe and heal dry skin and irritation. Created by board-certified dermatologist Dr. Joel Schlessinger and his son, Daniel Schlessinger, this product emerged after extensive testing of 54 different formulas to find the most effective solution. It is particularly beneficial for individuals dealing with dry skin conditions such as eczema, psoriasis, and those experiencing dryness due to medications.

This balm is available in a convenient stick form and is part of the LovelySkin line, offering a hydrocortisone-free option for those seeking relief from skin discomfort. Its patent-pending formula aims to improve the signs and symptoms associated with various dry skin issues, making it a supportive choice for your skincare routine.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and seborrheic dermatitis, as well as for relief from insect bites and reactions to poison oak or poison sumac. It can also help soothe itching caused by soaps, detergents, cosmetics, jewelry, and even external genital and feminine itching.

While this product is effective for these specific uses, any other applications should be discussed with your doctor to ensure safety and appropriateness.

Dosage and Administration

If you're dealing with itching caused by skin irritation, inflammation, or rashes, you can apply the medication to the affected area. For adults and children aged 2 years and older, it's recommended to use it no more than 3 to 4 times a day.

However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective relief from itching.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. You should not use it for treating diaper rash; if you have concerns about this condition, please consult your doctor for appropriate advice and treatment options.

Currently, there are no specified contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these guidelines.

Side Effects

It's important to use this product only on the skin and to avoid getting it in your eyes. If your condition worsens, or if your symptoms last more than 7 days or come back after clearing up, you should stop using the product and consult a doctor. Additionally, any use beyond the recommended guidelines should be done under a doctor's supervision.

Warnings and Precautions

This product is for external use only, so be sure to avoid getting it in your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and consult your doctor.

For any use beyond what is specified, it's important to seek advice and supervision from a healthcare professional. Always prioritize your health and safety when using any medication.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, general signs to watch for may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional advice in such situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including FixMySkin Healing Balm Unflavored (hydrocortisone ointment). Currently, there is no specific information available about the safety of using this product during pregnancy, which means that potential risks or necessary dosage adjustments have not been clearly defined.

Before using this ointment, you should consult with your healthcare provider to discuss any concerns and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can use FixMySkin Healing Balm Unflavored without specific warnings or recommendations against it. Currently, there is no information available about whether this product is passed into breast milk or if it poses any risk to your baby.

As always, if you have concerns about using any product while nursing, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is experiencing itching due to skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day if they are 2 years old or older. However, if your child is under 2 years of age, it’s important not to use this treatment without first consulting a doctor.

Always remember to keep this medication out of reach of children to ensure their safety.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 ideal range. 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 any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of the product.

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 FixMySkin Healing Balm Unflavored?

FixMySkin Healing Balm Unflavored is a balm formulated by dermatologist Dr. Joel Schlessinger and his son, designed to relieve dry skin and irritation from conditions like eczema and psoriasis.

What conditions can this balm help with?

This balm provides temporary relief for itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, insect bites, and more.

How should I use FixMySkin Healing Balm?

For adults and children 2 years and older, apply to the affected area 3 to 4 times daily. Do not use on children under 2 years without consulting a doctor.

Are there any contraindications for using this balm?

No specific contraindications are mentioned, but do not use it for diaper rash and consult a doctor for other uses.

What should I do if my condition worsens?

Stop using the balm and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is it safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of this balm during pregnancy or nursing.

How should I store FixMySkin Healing Balm?

Store the balm at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep the container tightly closed and discard after opening.

What precautions should I take while using this balm?

Use the balm for external use only and avoid contact with eyes. Keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Fixmyskin Healing Balm Unflavored (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fixmyskin Healing Balm Unflavored.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Formulated by board-certified dermatologist Dr. Joel Schlessinger and his son, Daniel Schlessinger, this balm product underwent a comprehensive five-year development process, resulting in a patent-pending formula after evaluating 54 different formulations. Designed specifically for dry skin, it effectively addresses the signs and symptoms associated with various conditions, including eczema, medication-induced dryness, psoriasis, and other dry skin disorders. Additionally, a variant of this product is available in the LovelySkin line, which does not contain hydrocortisone. For further details on the development of this product, visit www.FixMySkin.com/Story.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, and jewelry. It is also indicated for external genital and feminine itching, as well as for use as an external analgesic.

Limitations of use: Other applications of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For the management of itching associated with skin irritation, inflammation, and rashes, the following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should 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, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or further evaluation.

Contraindications

The product is contraindicated for the treatment of diaper rash. Consultation with a healthcare professional is advised in such cases.

Warnings and Precautions

For external use only; contact with eyes should be strictly avoided to prevent irritation or injury.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Any application of this product outside of the specified indications should occur only under the guidance and supervision of a qualified healthcare provider.

Side Effects

Patients should be aware that this product is for external use only and must be kept away from the eyes to prevent irritation or injury.

In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms clear up and then recur within a few days, it is recommended to seek medical advice. Any use of this product beyond the specified indications should occur only under the guidance and supervision of a healthcare provider.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Fixmyskin Healing Balm Unflavored (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fixmyskin Healing Balm Unflavored.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily.

For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised.

It is important to keep the medication out of reach of children to prevent accidental ingestion or misuse.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of FixMySkin Healing Balm Unflavored (hydrocortisone ointment) during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering this medication for pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of this product in pregnant women. Given the lack of information, it is advisable for healthcare providers to weigh the potential benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of FixMySkin Healing Balm Unflavored in lactating mothers. Additionally, there is no information available about the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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

In the context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Given the absence of detailed guidance, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage. In the event of an overdose, it is recommended that healthcare providers monitor the patient closely for any adverse effects or symptoms that may arise, even if they are not explicitly outlined in the drug insert.

Should an overdosage be suspected, supportive care should be initiated as necessary. This may include symptomatic treatment and monitoring of vital signs. Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for further guidance on management strategies tailored to the specific circumstances of the overdose.

In summary, while specific overdosage information is lacking, vigilance and appropriate supportive measures are essential in managing any potential cases of overdose.

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 question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. It is important to inform patients that this product is not intended for the treatment of diaper rash, and they should consult a doctor if they have questions regarding its use in such cases.

Patients should be instructed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, any use of this product beyond the specified indications should be conducted only under the guidance and supervision of a healthcare professional.

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, any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before 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 Fixmyskin Healing Balm Unflavored, 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 Fixmyskin Healing Balm Unflavored, 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.