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Fixmyskin Healing Balm Vanilla Flavor

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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
76314-004
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 Vanilla Flavor is a specially formulated product created by dermatologist Dr. Joel Schlessinger and his son, Daniel Schlessinger, after extensive research to find the best balm for dry skin. This balm is designed to provide temporary relief from itching and irritation associated with various skin conditions, including eczema, psoriasis, and minor skin irritations caused by insect bites or reactions to soaps and cosmetics.

The balm's unique formula helps improve the signs and symptoms of dry skin, making it suitable for use on affected areas, including external genital and feminine itching. It is important to use this product as directed and consult a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. This includes conditions like eczema, psoriasis, and seborrheic dermatitis, as well as reactions to insect bites, poison oak, and poison sumac. It can also help soothe irritation from soaps, detergents, cosmetics, and jewelry.

Additionally, this product is effective for relieving itching in external genital areas and can provide external pain relief (analgesic). If you have other uses in mind, it's best to consult with your doctor for guidance.

Dosage and Administration

If you're dealing with itching caused by skin irritation, inflammation, or rashes, you can apply the medication directly 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 use this product only as directed. Do not use it for treating diaper rash; if you have concerns about this condition, please consult your doctor. If your symptoms worsen, persist for more than 7 days, or improve and then return within a few days, stop using the product and seek medical advice.

Additionally, any use of this product outside of the specified purposes should be done only under the guidance and supervision of a healthcare professional. This ensures your safety and helps prevent any potential misuse or complications.

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 return shortly after improvement, you should stop using the product and consult a doctor. Additionally, any use beyond the recommended guidelines should be done under medical supervision.

Warnings and Precautions

This product is intended for external use only, so be sure to avoid getting it in your eyes. If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, 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 by following these guidelines.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

When it comes to using FixMySkin Healing Balm Vanilla Flavor during pregnancy, there is currently 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 guide you on the best choices for your health and your baby's well-being. Always prioritize open communication with your doctor regarding any medications or products you consider using during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. The safety of this product during lactation has not been fully established, so exercising caution is advised while using it. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help you understand how your kidney health 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 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 your medication is safe and effective for you.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

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 important to protect it from light, so keep it in its original packaging or a dark container. Always make sure the container is tightly closed when not in use to maintain its integrity.

Once you open the container, please remember to discard any remaining product after use to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and maintain its quality.

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 Vanilla Flavor?

FixMySkin Healing Balm Vanilla Flavor is a balm formulated by dermatologist Dr. Joel Schlessinger and his son, designed for dry skin and irritation. It helps improve the signs and symptoms of dry skin due to conditions like eczema and psoriasis.

What conditions can this balm help relieve?

The 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 warnings I should be aware of?

This product is for external use only and should not come into contact with eyes. Stop use and consult a doctor if the condition worsens or persists for more than 7 days.

Is it safe to use during pregnancy or while nursing?

The safety of FixMySkin Healing Balm during pregnancy has not been established. Nursing mothers should consult a doctor before use, as there is potential for excretion in breast milk.

What should I do if I experience side effects?

If you experience worsening symptoms or if symptoms persist for more than 7 days, stop using the balm and consult a doctor.

How should I store FixMySkin Healing Balm?

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

Packaging Info

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

Packaging configurations for Fixmyskin Healing Balm Vanilla Flavor.
Details

Drug Information (PDF)

This file contains official product information for Fixmyskin Healing Balm Vanilla Flavor, 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 five-year development process, resulting in a patent-pending formula after 54 iterations. Designed specifically for dry skin, it addresses the signs and symptoms associated with conditions such as eczema, medication-induced dryness, psoriasis, and other related skin issues. 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.

Additionally, this drug is indicated for the relief of external genital and feminine itching, as well as for use as an external analgesic.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

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 without prior consultation with a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

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

Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and recur within a few days, the use of this product should be discontinued, and a doctor should be consulted. Any application of this product outside of the specified indications should occur only under the guidance and supervision of a healthcare provider.

Warnings and Precautions

For external use only; it is imperative to avoid contact with the eyes. In the event of worsening conditions or if symptoms persist for more than 7 days, it is essential to discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. Any application of this product outside of the specified indications must be conducted under the guidance and supervision of a qualified healthcare provider.

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, patients are advised to stop use and consult a doctor. Any use of this product beyond the indicated purposes should be conducted under the guidance and supervision of a healthcare professional.

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 Fixmyskin Healing Balm Vanilla Flavor (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fixmyskin Healing Balm Vanilla Flavor.
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

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of FixMySkin Healing Balm Vanilla Flavor during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of available data when assessing the potential risks and benefits for pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that healthcare providers employ standard supportive care measures. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, it is essential to contact a poison control center or seek immediate medical attention for further guidance on management strategies.

As always, healthcare professionals should exercise clinical judgment and consider the individual patient's circumstances when addressing potential overdosage scenarios.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details have been provided 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 that they should consult a doctor for appropriate alternatives if needed.

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 only occur 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) and protected from light to ensure optimal stability and efficacy. Once opened, the product should be discarded to prevent any potential degradation or contamination.

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 Vanilla Flavor, 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 Vanilla Flavor, 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

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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.