Itch and Rash Cream

Description

1% Hydrocortisone Itch Cream is formulated for topical application and is designed to alleviate itching and inflammation associated with various skin conditions. The product is presented in a HYDRO POUCH, which ensures optimal delivery and stability of the active ingredient.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the product to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, the product should not be used without consulting a doctor.

In adults specifically for external anal itching, it is advised to first cleanse the affected area using a mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting and blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with a soft cloth prior to the application of the product.

For children under 12 years of age experiencing external anal itching, consultation with a doctor is recommended before use.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

External use only; this product is not intended for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor prior to use if they experience vaginal discharge associated with external feminine itching.

For external itching, it is crucial that patients do not exceed the recommended daily dosage. If bleeding occurs, the use of this product should be discontinued immediately. Patients should be instructed to seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using this product, it is imperative to avoid contact with the eyes. Patients must be cautioned against inserting this product into the rectum using fingers or any mechanical means. Additionally, the concurrent use of this product with any other Hydrocortisone product should only occur after consultation with a healthcare provider.

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

Side Effects

Patients using this product may experience a range of adverse reactions, which should be carefully monitored. Serious adverse reactions include the potential for worsening of the condition or persistence of symptoms beyond 7 days. In such cases, patients are advised to discontinue use and consult a healthcare professional.

Common adverse reactions may include localized irritation or discomfort, particularly if the product is applied excessively or inappropriately. It is crucial for patients to adhere to the recommended daily dosage and to avoid contact with the eyes. Additionally, patients should not use this product for the treatment of diaper rash or insert it into the rectum using fingers or any mechanical means.

In clinical practice, it is recommended that patients consult a doctor prior to use if they have a vaginal discharge associated with external feminine itching. Furthermore, the use of this product in conjunction with any other Hydrocortisone product should only occur after consultation with a healthcare provider to prevent potential adverse effects.

Patients should be vigilant for any signs of bleeding or other unusual symptoms during treatment and seek medical advice if such occurrences arise.

Drug Interactions

Co-administration of this product with other Hydrocortisone formulations is contraindicated unless a healthcare professional has been consulted. The potential for additive effects may increase the risk of adverse reactions associated with corticosteroid therapy. It is advisable to seek medical guidance to evaluate the necessity and safety of concurrent use, as well as to consider appropriate dosage adjustments or monitoring strategies based on the individual patient's clinical status.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 or 4 times daily. For children under 2 years of age, the medication is not recommended, and a healthcare professional should be consulted prior to use. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before application.

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 safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, the use of hydrocortisone cream should be carefully considered, weighing the benefits against the risks.

Dosage adjustments may be necessary for pregnant individuals, and it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Special precautions should be taken to use this medication only if clearly needed, ensuring that the potential benefits outweigh any associated risks during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, it should be kept out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically for adults and children aged 2 years and older, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed.

Patients are also counseled to consult a doctor prior to use if they have a vaginal discharge related to external feminine itching. It is important to avoid contact with the eyes and not to insert the product into the rectum using fingers or mechanical devices. Additionally, patients should refrain from using this product in conjunction with any other Hydrocortisone products without prior consultation with a healthcare provider. If the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, patients should seek medical advice.

Drug Information (PDF)

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

View product document (PDF)