Itch Relief

Description

CVS 340113 is a hydrocortisone cream formulated for topical application. It contains hydrocortisone as the active ingredient, which is a corticosteroid used to relieve inflammation and itching associated with various skin conditions. The cream is presented in a suitable dosage form for easy application and is designed to provide localized relief. The specific formulation details, including inactive ingredients and concentration, are proprietary to the manufacturer.

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 but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis, and sunburn. Additionally, it provides temporary relief for external anal and genital itching.

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

For the treatment of itching, skin irritations, inflammation, and rashes, the following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should apply the medication 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 and anal itching, adults are instructed to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleaning, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication 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 recommended prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not exceed the directed dosage unless advised by a healthcare professional. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators, as this may lead to complications or adverse effects.

Warnings and Precautions

For external use only; this product is contraindicated for application in the genital area, particularly in the presence of vaginal discharge.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or the occurrence of rectal bleeding. It is imperative that patients refrain from using any other hydrocortisone products unless directed by a healthcare provider.

Side Effects

Patients should be aware that the product is intended for external use only and should not be applied to the genital area if there is a vaginal discharge.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or if rectal bleeding is experienced. It is important for patients to refrain from using any other hydrocortisone products without prior consultation with a doctor in these situations.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations regarding dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Itch Relief (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is also recommended to seek medical advice prior to application.

For adults and children aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of hydrocortisone 1% cream as the drug insert does not provide dedicated data for this population. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to corticosteroids in older adults.

Due to the lack of specific clinical findings or dosage adjustments for elderly patients, it is advisable to monitor this population closely for any adverse effects or therapeutic responses. Adjustments to the treatment regimen may be necessary based on individual patient assessments, particularly in those with comorbidities or concurrent medications that could influence the safety and efficacy of hydrocortisone 1% cream.

Pregnancy

The safety of hydrocortisone 1% 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 this medication should be under medical supervision. Dosage adjustments may be necessary, and healthcare providers should be consulted for guidance on appropriate dosing. It is recommended that hydrocortisone 1% cream be used only if clearly needed, and when the benefits outweigh the risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: conditions worsen, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. It is important to inform patients not to initiate the use of any other hydrocortisone product without first consulting a healthcare professional. Additionally, patients should be made aware that rectal bleeding is a serious concern that requires medical attention.

While using this product, patients should be cautioned to avoid contact with the eyes. They should not exceed the recommended dosage unless specifically directed by a healthcare provider. Furthermore, patients must be informed that the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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 external and anal itching, it is advised that adults first clean the affected area with mild soap and warm water, rinsing thoroughly, and then gently drying the area by patting or blotting with toilet tissue or a soft cloth before application.

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

Drug Information (PDF)

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

View product document (PDF)