Equate Hydrocortisone

Description

NDC 79903-091-01 equate™ Hydrocortisone Cream is formulated to provide maximum strength relief for various skin conditions. This cream is designed to deliver fast itch relief for eczema, psoriasis, seborrheic dermatitis, and irritation caused by soaps, insect bites, and contact with poison ivy, oak, and sumac, among other skin irritations. The product is presented in a soothing and cooling cream dosage form, with a net weight of 1 oz (28 g). It is comparable to the active ingredient found in Cortaid®.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the management of itching associated with minor skin irritations, inflammation, and rashes, the recommended dosage is as follows: Adults and children aged 2 years and older should 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 doctor prior to use.

In cases of external anal and genital itching, the following procedure should be followed: Adults and children aged 12 years and older should first cleanse the affected area with mild soap or 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. The application should not exceed 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended before use.

Contraindications

Use is contraindicated in patients with a vaginal discharge; consultation with a healthcare professional is advised in such cases. Exceeding the recommended daily dosage is contraindicated unless directed by a physician. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is contraindicated for use in individuals with vaginal discharge; such patients should be instructed to consult a healthcare provider prior to use.

When utilizing this product, it is imperative that patients adhere to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare professional. Additionally, patients must be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or any occurrence of bleeding.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Finally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only, and contact with the eyes should be avoided. It is contraindicated for individuals with a vaginal discharge, and such patients should consult a healthcare professional prior to use.

During the use of this product, patients are advised not to exceed the recommended daily dosage unless directed by a healthcare provider. Additionally, it is important to refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of any bleeding also necessitates immediate consultation with a healthcare professional.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this product. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact should be made with a Poison Control Center at 1-800-222-1222.

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 drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For the treatment of itching associated with minor skin irritations, inflammation, and rashes, the recommended application for adults and children aged 2 years and older is to apply to the affected area no more than 3 to 4 times daily. In cases of external anal and genital itching, adults and children aged 12 years and older may apply to the affected area up to 3 to 4 times daily, while children under 12 years of age should also consult a doctor.

Geriatric Use

There is no specific information regarding the use of Equate Hydrocortisone Topical in geriatric patients. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and increased sensitivity to topical corticosteroids.

It is advisable to monitor geriatric patients closely for potential adverse effects and to consider individual patient factors, such as the presence of comorbidities and concurrent medications, which may necessitate dosage adjustments or heightened vigilance in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals are advised to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from 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 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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product if they have a vaginal discharge and to consult a doctor in such cases. It is important to instruct patients to stop using the product and seek medical advice 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 discontinue use and consult a healthcare professional if any bleeding occurs.

While using this product, patients must be cautioned not to exceed the recommended daily dosage unless directed by a healthcare provider. Furthermore, patients should be instructed not to insert the product into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product at a temperature range of 15 to 30°C (59 to 86°F). Healthcare professionals should ensure that the seal on the tube is intact; the product must not be used if the seal is broken or missing. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

For the management of itching associated with minor skin irritations, inflammation, and rashes, patients aged 2 years and older are advised to apply the treatment to the affected area no more than 3 to 4 times daily. For external anal and genital itching, the application is recommended for adults and children aged 12 years and older, also not exceeding 3 to 4 times daily. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)