Sunmark

Description

Hydrocortisone ointment 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 an ointment dosage form, classified as maximum strength. The net weight of the product is 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

When practical, the affected area should be cleansed with mild soap and warm water, followed by thorough rinsing. After cleansing, the area must be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. The use of this product is not recommended for children under 12 years of age; consultation with a healthcare professional is advised in such cases.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product if they have a vaginal discharge, as this may indicate an underlying condition that requires medical evaluation. Additionally, the product should not be used for the treatment of diaper rash or on children under 2 years of age due to safety concerns.

If bleeding occurs, or if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted. Furthermore, patients should refrain from using this product before initiating any other hydrocortisone treatment to avoid potential interactions or exacerbation of side effects.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes, as this may lead to irritation or injury. Additionally, the product should not be inserted into the rectum using fingers, mechanical devices, or applicators, as this could result in serious complications.

Patients should discontinue use and consult a healthcare professional if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical advice should also be sought. Furthermore, it is advisable to consult a doctor before initiating the use of any other hydrocortisone product.

This product should not be used without prior consultation with a healthcare provider if there is a vaginal discharge, if the intention is to treat diaper rash, or if the patient is under 2 years of age.

In the event 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 may experience a range of adverse reactions, which should be carefully monitored. The product is intended for external use only, and contact with the eyes should be avoided. It is crucial that patients do not insert this product into the rectum using fingers or any mechanical device or applicator.

In the event of bleeding, patients are advised to discontinue use and consult a doctor promptly. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought. Patients should also refrain from using this product before starting any other hydrocortisone treatment.

Specific contraindications include the presence of vaginal discharge, the treatment of diaper rash, and use in children under 2 years of age, all of which require consultation with a healthcare professional prior to use. For users treating external anal itching, it is important not to exceed the recommended daily dosage unless directed by a physician. Furthermore, children under 12 years of age should also consult a doctor before use.

Patients should keep this product 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 between the drug and 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). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product for the treatment of diaper rash without consulting a healthcare professional. For children under 2 years of age, it is essential to seek medical advice prior to use. Additionally, the product is not recommended for children under 12 years of age without prior consultation with a doctor.

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

Hydrocortisone ointment has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. As such, healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. It is advisable to monitor pregnant patients closely and to use clinical judgment in the context of individual patient circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to keep the medication out of the reach of children to prevent accidental ingestion.

Should ingestion occur, immediate medical assistance is crucial. Healthcare professionals are advised to contact a Poison Control Center or seek medical help without delay. Prompt intervention is essential to manage potential symptoms and mitigate any adverse effects associated with the 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 question.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. 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 the medication. Providers should remind patients to retain the carton, as it contains important information that may be necessary for safe and effective use of the product.

Storage and Handling

This product is supplied in various packaging configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 15° to 30°C (59° to 86°F) 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.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor before use.

Clinicians should counsel patients to read all label directions prior to using the medication and to retain the carton, as it contains important information. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)