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Sunmark Hydrocortisone with Aloe

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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 1995
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 1995
Label revision date
October 4, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M017
NDC root
49348-521
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

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.

The cream contains aloe, which can help soothe the skin while the hydrocortisone works to reduce inflammation and itching. 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. Before applying, it's best to clean the area gently with mild soap and warm water, then rinse it thoroughly. After cleaning, make sure to dry the area by patting or blotting it with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this product without consulting a doctor. Additionally, if your child is under 12 years of age, it's a good idea to check with a doctor before use to ensure it's safe for them.

What to Avoid

You should avoid using this product if you have a vaginal discharge; it's important to consult a doctor in that case. Additionally, do not use it before treating diaper rash or on children under 2 years of age. If your condition worsens, persists for more than 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Also, refrain from using this product before starting any other hydrocortisone product.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and return within a few days, stop using the product and consult a doctor. It's also important to avoid using 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, do not exceed the recommended daily dosage unless directed by a doctor. If you experience any bleeding, seek medical attention immediately. Additionally, do not insert this product into the rectum using fingers or any device. If the user is under 12 years old, consult a doctor before use. Always keep this and all medications out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If you experience any worsening of your condition, or if your symptoms last more than 7 days or return after clearing up, 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 old. Always check with your doctor before using any other hydrocortisone product.

It's important not to exceed the recommended daily dosage unless your doctor advises otherwise. If you notice any bleeding, seek medical attention promptly. For children under 12 years of age, please consult a doctor before use. If the product is swallowed, get emergency medical help or contact a Poison Control Center immediately.

Overdose

It's important to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. If you or someone else accidentally swallows this medication, seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell after taking the medication, don't hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned about using hydrocortisone cream during pregnancy. This means that the drug insert does not provide information on whether you need to adjust the dosage or take any special precautions while using this cream.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

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

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 your doctor's advice to ensure the safety and well-being of your child.

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 prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that 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 kidney function might affect the use of this medication.

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

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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how different treatments may work together and monitor your health appropriately.

Storage and Handling

To ensure the best results with 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 the seal has been broken, do not use the product; instead, return it to the store where you purchased it.

When you're ready to use the product, unscrew the cap, pull the tab to remove the foil seal, and then screw the cap back onto the tube. Following these steps will help maintain the product's safety and effectiveness.

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, insect bites, and poison ivy.

How should I apply hydrocortisone cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Cleanse the area with mild soap and warm water before application.

Are there any age restrictions for using this cream?

Do not use this product on children under 2 years of age without consulting a doctor. For children under 12 years, consult a doctor before use.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

What precautions should I take when using this cream?

This product is for external use only. Avoid contact with the eyes and do not use if you have a vaginal discharge or before treating diaper rash.

What should I do if I swallow hydrocortisone cream?

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

How should I store hydrocortisone cream?

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

Can I use hydrocortisone cream while pregnant or nursing?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or nursing.

Packaging Info

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

Packaging configurations for Sunmark Hydrocortisone with Aloe.
Details

Drug Information (PDF)

This file contains official product information for Sunmark Hydrocortisone with Aloe, 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 indicated for its antipruritic properties, effectively alleviating itching. The cream is designed with maximum strength and includes aloe as an additional feature. Each container has 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 resulting from exposure to 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 product should be applied to the affected area no more than 3 to 4 times daily. Prior to application, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product should not be used unless directed by a physician. Additionally, for children under 12 years of age, consultation with a healthcare professional is advised prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients presenting with vaginal discharge should not use this product and should consult a healthcare professional.

  • The product should not be applied prior to the treatment of diaper rash.

  • It is contraindicated for use in children under 2 years of age.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the product should be discontinued and a healthcare professional consulted. Prior to initiating any other hydrocortisone product, this product should also be discontinued.

Warnings and Precautions

This product is intended for external use only and should not come into contact with the eyes. Healthcare professionals should advise 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. Additionally, patients should consult a doctor before initiating the use of any other hydrocortisone product.

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

This product should not be used in the presence of vaginal discharge, prior to treating diaper rash, or on children under 2 years of age without consulting a healthcare professional.

General precautions include adherence to the recommended daily dosage, as exceeding this dosage should only occur under medical supervision. In cases of bleeding, patients are advised to consult a doctor promptly. It is also important to note that this product should not be administered rectally using fingers, mechanical devices, or applicators. For children under 12 years of age, consultation with a healthcare provider is recommended prior to use.

Side Effects

Patients using this product should be aware that it is intended 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 discontinue use and consult a doctor.

This product should not be used if patients have a vaginal discharge, before treating diaper rash, or on children under 2 years of age without prior consultation with a healthcare professional. For those using the product for external anal itching, it is crucial not to exceed the recommended daily dosage unless directed by a doctor. Should any bleeding occur, patients must seek medical attention promptly. Additionally, it is advised that children under 12 years of age consult a doctor before 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 recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Sunmark Hydrocortisone with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children under 12 years of age, it is advised to consult a healthcare professional prior to use.

For pediatric 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to ensure that this and all medications are stored out of the reach of children to prevent accidental ingestion.

Should an overdose occur, immediate medical assistance is required. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the medication is swallowed. Prompt intervention is crucial in managing potential complications 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 use of the compound in these contexts.

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 and all other drugs out of the reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

It is essential for patients to read all label directions before using the medication. Providers should emphasize the importance of keeping the carton, as it contains important information that may be necessary for safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a tube with a cap. It is essential to store the product at a controlled room temperature between 59°F and 86°F.

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 reference, the lot number and expiration date can be found on the carton or the crimp of the tube.

To access the product, the user should unscrew the cap, pull the tab to remove the foil seal, and then securely screw the cap back onto the tube after use.

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 with Aloe, 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 with Aloe, 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.