Hydrocortisone

Description

This product is presented in a 28.4 g tube carton. The principal display panel includes a visual representation of the carton, which is depicted in an accompanying image. The effective date for this labeling is July 25, 2025.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it provides temporary relief for external anal and genital itching.

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

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application in the genital area is not recommended for patients with vaginal discharge; consultation with a healthcare professional is advised.

• The product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should discontinue use and seek medical advice if any of the following occur:

• The condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

• Rectal bleeding is observed.

While using this product, it is essential to avoid contact with the eyes, adhere to the directed dosage unless otherwise instructed by a healthcare professional, and refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it is not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes while using this product. It is imperative that patients adhere strictly to the recommended dosage; they should not exceed the directed amount unless specifically instructed by a healthcare provider.

Patients must be cautioned against the direct application of the product into the rectum using fingers or any mechanical device or applicator. If the patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, they should discontinue use and consult a doctor. Furthermore, if rectal bleeding occurs, patients should stop use immediately and seek medical attention.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should be advised to seek medical help or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. It is also recommended not to initiate the use of any other hydrocortisone product without consulting a doctor. In the event of rectal bleeding, patients should stop using the product and consult a healthcare provider immediately.

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

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years of age, it is recommended to seek medical advice before using the product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of hydrocortisone during pregnancy. Consequently, the safety of hydrocortisone in pregnant patients has not been established, and there are no documented dosage modifications or special precautions recommended for this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering hydrocortisone therapy for women of childbearing potential. It is advisable to monitor pregnant patients closely and to discuss the potential implications with them, given the lack of comprehensive data on fetal outcomes associated with hydrocortisone use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the clinical situation and the absence of documented risks.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, they should be cautioned against using the product for the treatment of diaper rash and to seek medical advice if needed.

Healthcare providers should emphasize that patients must 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. Patients should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor.

It is important to inform patients to stop using the product and seek medical attention if they experience rectal bleeding. While using the product, patients should be instructed to avoid contact with their eyes.

Patients should be reminded not to exceed the recommended dosage unless directed by a doctor. Furthermore, they should be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tamper-evident tube. It is essential to avoid using the product if the pull tab seal on the tube has been removed.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Users are advised to check the carton or the tube crimp for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for both adults and children aged 2 years and older. For adults specifically addressing external anal and genital itching, the same application frequency applies.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)