Kera Hc

Description

KERA HC Cream is a topical formulation containing hydrocortisone at a concentration of 1%. The product is packaged in a 2-ounce (56-gram) container, with the National Drug Code (NDC) 44577-623-02. The cream is designed for dermatological use and is identified by the brand name KERAHC.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammations, and rashes due to various conditions, including excessively dry skin, eczema, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

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 application is to the affected area not more than 3 to 4 times daily. It is important to note that this medication is contraindicated for use in children under 2 years of age. Healthcare professionals should ensure that patients are advised on the appropriate frequency of application to avoid excessive use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that the product should not be used in excess of the directed dosage unless instructed by a healthcare professional.

Warnings and Precautions

This product is intended for external use only. In the event of accidental ingestion, it is imperative to contact a physician or poison control center immediately for guidance.

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 initially improve but then return. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms initially improve and then return, medical advice should be sought.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. Safety and efficacy have not been established in this age group, and caution is advised when considering treatment options for infants and toddlers.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of KERA HC Cream (Hydrocortisone 1%) during pregnancy. As such, the safety of this medication in pregnant patients has not been established. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential. Due to the lack of data on dosage modifications or special precautions for use during pregnancy, it is advisable to exercise caution and consult relevant clinical guidelines or experts when making treatment decisions for pregnant patients.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering to lactating mothers. The effects on breastfed infants are not well studied, and thus, the risks versus benefits should be carefully considered.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific antidotes or additional management strategies tailored to the substance involved in the overdose. Continuous monitoring and supportive care remain the cornerstones of effective management in such scenarios.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to contact their physician or a poison control center immediately if the product is swallowed. It is important for patients to understand that they should stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return.

When using this product, patients must be cautioned to avoid contact with their eyes. Additionally, they should not exceed the recommended dosage unless directed to do so by a healthcare professional.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity during storage.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 4 times daily. It is for external use only, and patients are advised to avoid contact with the eyes. They should not exceed the directed usage unless instructed by a physician. If the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then return, patients should discontinue use and consult a doctor.

Clinicians should counsel patients to keep the product out of reach of children and to seek immediate medical attention if swallowed, contacting a physician or poison control center. The medication should be stored at room temperature, between 20-25 degrees C (68-77 degrees F).

Drug Information (PDF)

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

View product document (PDF)