Symptom checker
Select audience type

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

ADD CONDITION

items per page

Sunmark Hydrocortisone Plus

Last content change checked dailysee data sync status

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 1989
Label revision date
October 4, 2024
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 1989
Label revision date
October 4, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M017
NDC root
49348-441
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

Hydrocortisone cream 1% is a topical medication designed to provide temporary relief from itching associated with various minor skin irritations, inflammation, and rashes. This cream is particularly effective for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations caused by soaps, detergents, cosmetics, and jewelry.

In addition to its anti-itch properties, hydrocortisone cream contains 12 moisturizers to help soothe and hydrate the skin. It is important to use this product as directed, and for any other uses, you should consult with a doctor for guidance.

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 such as eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants like poison ivy, oak, and sumac. Additionally, it may relieve discomfort caused by soaps, detergents, cosmetics, jewelry, and external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure safety and effectiveness.

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 up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely. Remember, it is for external use only, so do not apply it internally. Additionally, be careful to avoid contact with your eyes, as this could cause irritation or discomfort. Following these guidelines will help ensure you use the product effectively and safely.

Side Effects

You should use this product only on the skin and avoid getting it in your eyes. If your condition worsens, symptoms last more than seven days, or if they improve and then return shortly after, stop using the product and consult a doctor. It's important not to use this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years old.

For those using it for external anal itching, do not exceed the recommended dosage unless directed by a doctor. If you experience any bleeding, seek medical advice immediately. Avoid inserting the product into the rectum with fingers or any device. If the product is swallowed, contact a Poison Control Center or seek medical help right away. Always keep this and all medications out of children's reach.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If you notice that your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. Additionally, do not use this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years of age.

For those using it for external anal itching, be careful not to exceed the recommended daily dosage unless your doctor advises otherwise. If you experience any bleeding, seek medical attention immediately. Also, do not insert this product into the rectum using fingers or any device. If the user is under 12 years old, please consult a doctor before use.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center right away.

Overdose

It's important to follow the recommended daily dosage of this medication and not exceed it unless your doctor advises you to do so. If you experience any unusual bleeding, consult your doctor immediately. Additionally, avoid inserting this product into the rectum using your fingers or any devices, as this can lead to complications.

If you or someone else accidentally swallows this medication, seek medical help or contact a Poison Control Center right away. This is especially crucial for children under 12 years of age, who should always be discussed with a doctor before use. Being aware of these guidelines can help ensure your safety and well-being.

Pregnancy Use

You can feel reassured that there are no specific warnings or precautions regarding the use of Hydrocortisone Plus during pregnancy mentioned in the available information. The insert does not indicate whether this product is contraindicated (not recommended) for pregnant individuals or if there are any risks to the developing fetus.

Additionally, there are no dosage modifications or special precautions outlined for those who are pregnant. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it can be passed into your breast milk, which means it could affect your nursing infant. Therefore, exercising caution is advised when considering this product while you are breastfeeding, as there may be risks involved for your baby. Always prioritize your health and your infant's safety by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children between 2 and 12 years of age, you should also check with a doctor before using it.

For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or adjustments mentioned for age-related considerations. This means that, as an older adult or caregiver, you should be aware that the standard dosage and safety measures apply without special modifications for age.

However, it's always important to consult with a healthcare provider about any potential risks or concerns, especially since older adults may have different health needs or conditions that could affect how they respond to medications. Always prioritize open communication with your doctor to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning optimally.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help determine the best course of action based on your individual 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 or how it should be managed in the context of liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help you understand how your liver condition may interact with medications and what steps to take for your health.

Drug Interactions

It's important to talk to your healthcare provider before using any other hydrocortisone product. This ensures that you avoid any potential interactions that could affect your treatment.

While there are no specific interactions with laboratory tests mentioned, discussing all medications and tests with your doctor is crucial for your safety and well-being. Always keep your healthcare team informed about what you are taking to help them provide the best care for you.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 59°F and 86°F (15°C to 30°C). It's important to check the carton or tube crimp for the lot number and expiration date to confirm its validity.

If you notice that the seal has been broken, do not use the product. Instead, return it to the store where you purchased it for a replacement. 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 the patient is under 2 years old, consult a doctor before use.

It's important to keep this and all medications out of the reach of children. If the medication is swallowed, seek medical help or contact a Poison Control Center immediately. Always read the label directions carefully and keep the carton, as it contains important information.

FAQ

What is hydrocortisone cream 1% used for?

Hydrocortisone cream 1% 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 apply hydrocortisone cream?

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

Are there any warnings for using hydrocortisone cream?

Yes, it is for external use only and you should avoid contact with the eyes. If your condition worsens or persists for more than 7 days, consult a doctor.

Can I use hydrocortisone cream if I am pregnant?

The insert does not mention any specific contraindications for use during pregnancy, but it is advisable to consult a doctor before use.

What should I do if I accidentally swallow hydrocortisone cream?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is hydrocortisone cream safe for children?

Children under 2 years of age should not use this product without consulting a doctor, and children under 12 years should consult a doctor before use.

What should I do if I experience bleeding while using hydrocortisone cream?

If you experience bleeding, consult a doctor promptly.

How should I store hydrocortisone cream?

Store at controlled room temperature between 59°F and 86°F. If the seal is broken, do not use the product.

Packaging Info

Below are the non-prescription pack sizes of Sunmark Hydrocortisone Plus (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunmark Hydrocortisone Plus.
Details

Drug Information (PDF)

This file contains official product information for Sunmark Hydrocortisone Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone cream 1% contains hydrocortisone as the active ingredient at a concentration of 1%. This formulation is designed for antipruritic use, providing relief from itching. It is presented in a cream dosage form, specifically labeled as MAXIMUM STRENGTH PLUS 12 MOISTURIZERS. The product is packaged in a net weight of 1 ounce (28.4 grams).

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external genital and anal areas.

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 adults and children aged 2 years and older, the recommended application is to the affected area not 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 product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

The product is contraindicated for external use only and should not be applied in or around the eyes. Contact with the eyes may result in irritation or adverse effects.

Warnings and Precautions

For external use only, this product should be applied with caution to avoid contact with the eyes. Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to seek medical advice before initiating the use of any other hydrocortisone product.

This product is contraindicated in patients with vaginal discharge and should not be used for treating diaper rash. It is also not recommended for use in children under 2 years of age without prior consultation with a healthcare provider.

For patients experiencing external anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a physician. In the event of bleeding, patients should seek medical attention promptly. Furthermore, this product should not be administered rectally using fingers or any mechanical device or applicator. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

In cases of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it 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 recur within a few days, patients are advised to stop using the product and consult a doctor. Additionally, patients should refrain from using this product if they have a vaginal discharge, before treating diaper rash, or before using it on children under 2 years of age.

For those using the product for external anal itching, it is crucial not to exceed the recommended daily dosage unless directed by a healthcare professional. Should any bleeding occur, patients must consult a doctor promptly. Furthermore, the product should not be inserted into the rectum using fingers or any mechanical device or applicator. For children under 12 years of age, it is recommended to consult a doctor prior to use.

Patients should keep this and all medications out of the reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

Before initiating treatment with any hydrocortisone product, it is imperative to consult a healthcare professional. This precaution is essential to ensure the safe and effective use of hydrocortisone, as potential interactions with other medications may exist.

Currently, there are no specific drug or laboratory test interactions documented in the available data. However, healthcare providers should remain vigilant and consider the patient's overall medication regimen and laboratory test results when prescribing hydrocortisone. Regular monitoring may be advisable to assess the patient's response to treatment and to identify any unforeseen interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Sunmark Hydrocortisone Plus (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunmark Hydrocortisone Plus.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; caregivers are advised to consult a doctor. For children under 12 years of age, it is recommended to seek medical advice prior to use.

In patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information available regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone Plus has not been associated with specific warnings or precautions for use during pregnancy. The available information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding due to the potential risk to the infant.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data may necessitate individualized assessment and monitoring based on clinical judgment.

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 event of overdosage, it is imperative that healthcare professionals adhere to the following guidelines to ensure patient safety and effective management.

Recommended Dosage Compliance Patients should not exceed the recommended daily dosage unless specifically directed by a healthcare provider. Adherence to prescribed dosages is crucial to prevent potential adverse effects associated with overdosage.

Symptoms and Immediate Actions In cases where the product is ingested, it is essential to seek medical assistance immediately or contact a Poison Control Center. Prompt action is vital to mitigate any harmful effects that may arise from overdosage.

Management of Specific Symptoms Should the patient experience bleeding, it is critical to consult a healthcare professional without delay. This symptom may indicate a serious condition requiring immediate medical intervention.

Special Considerations for Pediatric Patients For children under the age of 12, it is advised to consult a healthcare provider prior to administration. This precaution helps to ensure the safety and appropriateness of the treatment for younger patients.

Administration Guidelines It is important to note that the product should not be inserted into the rectum using fingers, mechanical devices, or applicators. Such actions may lead to complications and should be strictly avoided.

By following these guidelines, healthcare professionals can effectively manage cases of overdosage and ensure the safety of their patients.

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 medication and all other drugs out of the reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is essential for patients to read all label directions before using any medication. Providers should remind patients to keep the carton, as it contains important information regarding the product.

Patients should be informed that this medication is for external use only and must be used as directed. They should be cautioned to avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should instruct patients to discontinue use 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. Additionally, patients should be advised to stop using this product and consult a doctor before starting any other hydrocortisone product to avoid potential interactions or complications.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature between 59°F and 86°F (15°C to 30°C) to maintain its efficacy.

In the event that the seal has been broken, the product should not be used and must be returned to the place of purchase. For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube. Proper handling and storage are essential to ensure the product's integrity and safety.

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.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed. Patients are also encouraged to read all label directions carefully and retain the carton for important information.

Drug Information (PDF)

This file contains official product information for Sunmark Hydrocortisone Plus, 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 Sunmark Hydrocortisone Plus, 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.