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Unishield 1%

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
September 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
September 24, 2025
Manufacturer
Unishield
Registration number
M017
NDC root
49314-0005
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

This medication provides temporary relief from itching caused by various minor skin irritations, including inflammation and rashes due to conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and minor scrapes.

While it is effective for these uses, it's important to consult with a doctor for any other applications. This ensures that you are using the medication safely and appropriately for your specific needs.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin issues. You can use it for discomfort related to skin irritations, inflammation, and rashes that may arise from conditions like eczema, insect bites, or contact with plants such as poison ivy, poison oak, and poison sumac. It can also help with reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and minor scrapes.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area 3 to 4 times a day. For children under 12 years old experiencing external anal itching, it’s important to consult a doctor before use. If your child is under 2 years old, do not use this product without first speaking to a doctor.

For adults dealing with external anal itching, it’s best to start by gently cleansing the affected area with mild soap and warm water. Make sure to rinse thoroughly, or you can use a suitable cleansing pad to clean the area. After cleansing, gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying the medication. This preparation helps ensure the product works effectively.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always prioritize safety and follow these guidelines to ensure proper use.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to areas such as the eyes, ears, or mouth, and do not use it for treating diaper rash or feminine itching. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if your condition worsens, lasts more than 7 days, or if it clears up and then comes back within a few days. Additionally, if you experience any bleeding or plan to use another hydrocortisone product, it's best to speak with a doctor first.

Warnings and Precautions

This product is for external use only, so please avoid using it for diaper rash, in your eyes, or for feminine itching. While using this product, be careful to keep it away from your eyes, ears, and mouth. If it accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult your doctor if your condition worsens, lasts more than 7 days, or clears up only to come back within a few days. Additionally, if you start using another hydrocortisone product without consulting your doctor, or if you experience any bleeding, it's important to seek medical advice.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

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, you should call your local emergency number 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

When considering the use of Unishield 1% hydrocortisone cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no established guidelines or known risks associated with its use in pregnancy.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including topical treatments like hydrocortisone cream. They can help you weigh the potential benefits and risks based on your individual health needs.

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, and the safety of this product during lactation (the period of breastfeeding) has not been established. Therefore, exercising caution is advised when considering its use while nursing. Your healthcare provider can help you weigh the benefits and risks to ensure the best outcome for you and your baby.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area 3 to 4 times a day. However, if your child is under 12 years old and experiencing external anal itching, it's important to consult a doctor before use. For children under 2 years of age, you should not use this medication without first speaking to a doctor. Always prioritize your child's safety and seek professional advice when needed.

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, always consult with a healthcare provider before starting a new medication. They can help assess any potential risks and ensure that the treatment is safe and appropriate for your individual health needs.

Remember, older adults may have different responses to medications, so discussing any concerns or existing health conditions with your doctor is essential for safe and effective care.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature and avoid freezing it. It's important to keep the product in its original packaging and only use packets that are unopened and undamaged. If you find any packets that are opened or torn, do not use them, as this could compromise the product's integrity.

By following these simple storage and handling guidelines, you can help maintain the quality and effectiveness of the product.

Additional Information

For adults and children aged 2 years and older, you should apply the product to the affected area 3 to 4 times daily. If you are treating children under 12 years for external anal itching, it's best to consult a doctor first. For children under 2 years, do not use the product without consulting a doctor.

Before applying the product for external anal itching, adults should cleanse the affected area with mild soap and warm water, rinsing thoroughly. Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is this product used for?

This product provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I use this product?

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

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it for diaper rash, in the eyes, or for feminine itching.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this product while pregnant or breastfeeding?

Consult your doctor before using this product if you are pregnant or nursing, as safety during lactation has not been established.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, lasts more than 7 days, or if bleeding occurs.

How should I store this product?

Store at room temperature and do not freeze. Ensure packets are not opened or torn before use.

Packaging Info

Below are the non-prescription pack sizes of Unishield 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unishield 1%.
Details

Drug Information (PDF)

This file contains official product information for Unishield 1%, 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 various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area 3 to 4 times daily. Prior to application, adults experiencing external anal itching are advised to cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 12 years of age, particularly for external anal itching, it is recommended to consult a healthcare professional prior to use. The product is not indicated for use in children under 2 years of age; consultation with a doctor is necessary in such cases.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only, this product is contraindicated for the treatment of diaper rash, application in the eyes, and for feminine itching. Healthcare professionals should advise patients to avoid contact with the eyes, ears, and mouth during use. In the event of accidental contact with the eyes, it is imperative to rinse the eyes thoroughly with water.

Patients should be instructed to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should seek medical advice before using any other hydrocortisone products concurrently. Immediate medical attention is required if bleeding occurs.

In cases of ingestion, patients should seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only and is not suitable for the treatment of diaper rash, application in the eyes, or for feminine itching. It is important to avoid contact with the eyes, ears, and mouth during use. In the event of accidental contact with the eyes, patients should rinse thoroughly with water.

Participants are advised to discontinue use and consult a healthcare professional if the condition worsens, persists for more than 7 days, or if symptoms clear and then recur within a few days. Additionally, patients should seek medical advice before using any other hydrocortisone product concurrently. The presence of bleeding during use also necessitates immediate consultation with a doctor.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Unishield 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unishield 1%.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use. The medication is contraindicated in children under 2 years of age; consultation with a doctor is required for this age group.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Unishield 1% hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered if necessary. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider during pregnancy.

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 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, altered mental status, or any unusual physiological responses.

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. Healthcare professionals should also consider contacting a poison control center for additional 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be kept at room temperature. It is important to note that freezing the product is not permitted, as it may compromise its integrity and effectiveness.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor. The product is not recommended for use in children under 2 years of age without consulting a doctor. Clinicians should instruct adults to cleanse the affected area with mild soap and warm water, rinsing thoroughly or patting with an appropriate cleansing pad before application. It is important to gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to using the product.

Drug Information (PDF)

This file contains official product information for Unishield 1%, 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 Unishield 1%, 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.