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Nizoral Scalp Itch Relief

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Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Shampoo
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Shampoo
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 2024
Label revision date
December 23, 2025
Manufacturer
Kramer Laboratories
Registration number
M017
NDC root
55505-222
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

Nizoral® is a medicated solution designed to provide relief from scalp itch caused by conditions such as seborrheic dermatitis, psoriasis, and eczema. Its active ingredient, hydrocortisone (a type of steroid that reduces inflammation), works to soothe and calm an irritated scalp. The formula is enriched with aloe, menthol, vitamin E, and hyaluronic acid, which help to hydrate and comfort the skin.

This product is specifically formulated to temporarily relieve itching associated with minor skin irritations and inflammation. Nizoral® is paraben-free, fragrance-free, and has a greaseless texture, making it easy to apply with its tapered bottle tip design.

Uses

This product is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful if you are dealing with conditions like eczema, psoriasis, or seborrheic dermatitis.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

To use this medication effectively, start by twisting the applicator tip to open it. If you’ve just shampooed your hair, make sure to towel dry it before applying the solution. Gently squeeze the bottle to avoid any excess dripping, and apply the solution directly to your scalp, massaging it in for better absorption. After you’re done, remember to twist the applicator tip tightly to close it securely.

For adults and children aged 2 years and older, you can apply the solution to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this medication without consulting a doctor first.

What to Avoid

It's important to use this product safely. You should not use it for treating diaper rash; if you have any concerns, please consult your doctor. Additionally, if you are allergic to any ingredient in this product, you should avoid using it.

Make sure to keep the product away from your eyes, and do not exceed the recommended dosage unless your doctor advises you to do so. Following these guidelines will help ensure your safety while using this product.

Side Effects

You should use this product only as directed and for external use only. It is flammable, so keep it away from fire or flames. If your condition worsens, if 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. It's important not to use this or any other hydrocortisone product without first speaking to a healthcare professional.

Warnings and Precautions

This product is for external use only, so be sure to follow the directions carefully. It is flammable, so keep it away from fire or flames. Always store it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using this product and consult your doctor. It's important not to use this or any other hydrocortisone product without first checking with a healthcare professional.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications. The information available does not specify how this product may affect you during pregnancy, including whether it is safe to use, if you need to adjust the dosage, or if there are any special precautions to consider.

Before taking this product, you should discuss it with your healthcare provider to ensure it is appropriate for your situation. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding and considering using Nizoral Scalp Itch Relief (hydrocortisone shampoo), it's important to note that the drug insert does not provide specific information about its use during nursing. This means there are no established guidelines or known effects on breast milk or your nursing infant.

As always, it's best to consult with your healthcare provider before using any medication while breastfeeding to ensure it is safe for you and your baby. They can help you weigh the benefits and any potential risks.

Pediatric Use

If your child is 2 years old or 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 of age, it’s important not to use this medication without consulting a doctor first. Always prioritize your child's safety and seek professional advice when needed.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains essential information about the product that you may need later.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines 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 daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this product without consulting a doctor first.

Before using the medication, make sure to read all the label information carefully. If you experience any adverse reactions, contact your doctor and report the issue by calling 1-800-824-4894.

FAQ

What is Nizoral® used for?

Nizoral® is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, and seborrheic dermatitis.

What is the active ingredient in Nizoral®?

The active ingredient in Nizoral® is Hydrocortisone 1%, which helps relieve scalp itch.

How should I apply Nizoral®?

Twist the applicator tip to open, apply the solution directly to the scalp, and massage it in. For best results, apply to towel-dried hair and do not use more than 3 to 4 times daily.

Are there any contraindications for using Nizoral®?

Do not use Nizoral® for the treatment of diaper rash or if you are allergic to any ingredient in the product. Avoid contact with the eyes.

What should I do if my condition worsens?

Stop using Nizoral® and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Is Nizoral® safe to use during pregnancy?

The insert does not provide specific information regarding the use of Nizoral® during pregnancy, so consult your doctor for advice.

What precautions should I take when using Nizoral®?

Use Nizoral® only as directed, keep it out of reach of children, and store it at 20-25°C (68-77°F).

Can children use Nizoral®?

Children 2 years of age and older can use Nizoral®, but it should not be used in children under 2 years of age without consulting a doctor.

Packaging Info

Below are the non-prescription pack sizes of Nizoral Scalp Itch Relief (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nizoral Scalp Itch Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, psoriasis, and seborrheic dermatitis.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

The applicator tip should be twisted to open prior to use. For optimal application, if the solution is being applied after shampooing, it is recommended to towel dry the hair before proceeding. The bottle should be squeezed gently to prevent excess dripping of the solution. The solution must be applied directly to the scalp, followed by a gentle massage to ensure even distribution.

For adults and children aged 2 years and older, the solution should be applied to the affected area no more than 3 to 4 times daily. It is important to twist the applicator tip tightly after use to maintain the integrity of the product. For children under 2 years of age, the use of this product is not recommended; consultation with a healthcare professional is advised.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, individuals with a known allergy to any ingredient in this product should refrain from its use.

Contact with the eyes must be avoided, and the product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider.

Warnings and Precautions

For external use only; it is imperative that this product is utilized strictly as directed to ensure safety and efficacy. The formulation is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous incidents.

General precautions should be observed to ensure the safety of all users. This product must be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. It is crucial that patients do not use this or any other hydrocortisone product without prior consultation with a healthcare provider.

Side Effects

Patients should be aware that the product is for external use only and must be used strictly as directed. It is important to note that the product is flammable; therefore, it should be kept away from fire or flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional 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, patients should not use this or any other hydrocortisone product without first consulting a doctor.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nizoral Scalp Itch Relief (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nizoral Scalp Itch Relief.
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, the use of this medication is not recommended; caregivers should consult a physician for guidance.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to monitor any emerging data related to fetal outcomes as it becomes available.

Lactation

There is no specific information regarding the use of Nizoral Scalp Itch Relief (hydrocortisone shampoo) in lactating mothers or lactation considerations. The prescribing information does not provide data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

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

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an 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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. It is essential to discuss any known allergies to ingredients in this product, as this may affect its use.

Healthcare providers should instruct patients to avoid contact with the eyes to prevent irritation or injury. Patients must be cautioned against using more of the product than directed unless specifically advised to do so by a doctor.

Additionally, patients should be made aware that they should stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important to emphasize that they should not use this or any other hydrocortisone product without first consulting a doctor.

Storage and Handling

The product is supplied in a carton that contains essential information regarding its use and handling. It is important to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Users are advised to retain the carton for reference to the full product information.

Additional Clinical Information

The product 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.

Patients are encouraged to read all label information prior to use. In the event of a drug reaction, they should contact a healthcare professional and report the incident by calling 1.800.824.4894. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Nizoral Scalp Itch Relief, 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 Nizoral Scalp Itch Relief, 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.