Symptom checker
Select audience type

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

ADD CONDITION

items per page

Fixmyskin Healing Balm Fragrance-Free

Last content change checked dailysee data sync status

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 2009
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 2009
Label revision date
December 31, 2024
Manufacturer
Lovely Skin, Inc.
Registration number
M017
NDC root
76314-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 Fragrance-Free is a specially formulated balm designed to help soothe and heal dry skin. Created by dermatologist Dr. Joel Schlessinger and his son, Daniel, this product emerged from a five-year effort to develop an effective stick balm for various dry skin conditions, including eczema, psoriasis, and dryness caused by medications.

This balm is notable for its patent-pending formula, which aims to improve the signs and symptoms associated with dry skin. It is also available in a version without hydrocortisone, making it a versatile option for those seeking relief from skin irritation. For more details about its development, you can visit www.FixMySkin.com/Story.

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 plants like poison oak and poison sumac. It can also help soothe itching caused by soaps, detergents, cosmetics, jewelry, and even external genital and feminine itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

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 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 longer 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 intended for external use only, so be sure to avoid getting it in your eyes. It is not suitable for treating diaper rash, so if you have concerns about that, please consult your doctor.

If your condition worsens, or if your symptoms last longer than 7 days or come back shortly after improving, stop using the product and reach out to your doctor for guidance. For any other uses not mentioned, it's important to seek your doctor's advice and supervision before proceeding.

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, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an 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 assistance if you think something is wrong.

Pregnancy Use

When it comes to using FixMySkin Healing Balm 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 weigh the potential benefits and risks based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

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 medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to ensure the best care for your health.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps 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 FixMySkin Healing Balm Fragrance-Free used for?

FixMySkin Healing Balm is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I use FixMySkin Healing Balm?

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

Are there any contraindications for using this balm?

No specific contraindications are mentioned, but do not use it for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop using the balm and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or recur within a few days.

Is FixMySkin Healing Balm safe to use during pregnancy?

The insert does not provide specific information regarding the use of FixMySkin Healing Balm during pregnancy.

Can nursing mothers use this product?

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

How should I store FixMySkin Healing Balm?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

What should I avoid while using this balm?

Avoid contact with eyes and do not use for the treatment of diaper rash without consulting a doctor.

Packaging Info

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

Packaging configurations for Fixmyskin Healing Balm Fragrance-Free.
Details

Drug Information (PDF)

This file contains official product information for Fixmyskin Healing Balm Fragrance-Free, 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 extensive development over five years, 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 conditions such as eczema, psoriasis, and medication-induced dryness. Additionally, a variant of this product is available in the LovelySkin line, which does not contain hydrocortisone. For further details on the development process, 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.

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 relief 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 prior to use in this context.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided. This product is not indicated for the treatment of diaper rash. In such cases, consultation with a healthcare professional is advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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 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 clear up and then occur again 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 Fragrance-Free (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fixmyskin Healing Balm Fragrance-Free.
Details

Pediatric Use

For the management of itching associated with skin irritation, inflammation, and rashes, the product is indicated for use in adults and children aged 2 years and older. The recommended application is to the affected area not more than 3 to 4 times daily.

In pediatric patients under 2 years of age, the product should not be used without consulting a doctor. Additionally, it is important to keep the product out of reach of children to ensure safety.

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 during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to consult with a healthcare provider for individualized recommendations.

Lactation

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

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, it is important to note that there is no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

Given the lack of specific overdosage information, healthcare professionals are encouraged to consult local poison control centers or relevant medical authorities for guidance on management strategies tailored to the individual case. Continuous assessment and appropriate interventions are essential to ensure patient safety and mitigate any potential risks associated with overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 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 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 its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

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, 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 Fragrance-Free, 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 Fragrance-Free, 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.