Anti-Itch with Aloe

Description

The product is identified by the SPL code 34089-3 and is formulated as a hydrocortisone cream containing aloe. It is packaged in a 1-ounce container. The formulation is designed for topical application and is intended for use in dermatological conditions. The product is referenced as 99259 QC HYDROCORTISONE CREAM WITH ALOE, with the revision date noted as 030624 by the Center for Drug Evaluation and Research (CDER).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes resulting from various conditions. These conditions include insect bites, eczema, poison ivy, poison oak, poison sumac, reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external and anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, or patting or blotting with toilet tissue or a soft cloth.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and refrain from initiating any other hydrocortisone product without medical guidance if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management. Additionally, in cases of external genital itching accompanied by vaginal discharge, it is imperative to seek medical advice before use.

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

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should patients initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Side Effects

Patients should be aware that the product is intended for external use only. It is not recommended for the treatment of diaper rash; individuals should consult a doctor for appropriate treatment in such cases. Additionally, for external genital itching accompanied by vaginal discharge, it is advised to seek medical consultation prior to use.

In the event that conditions worsen or symptoms persist for more than 7 days, patients should discontinue use of the product. If symptoms clear up and then recur within a few days, patients are advised not to resume use of this product or any other hydrocortisone product unless directed by a healthcare professional.

Drug Interactions

The initiation of any hydrocortisone product should be preceded by consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions with other medications that the patient may be taking.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not indicated at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For patients aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age experiencing external anal itching should consult a doctor before use.

Geriatric Use

Geriatric patients, defined as individuals aged 65 years and older, have not been specifically addressed in the provided prescribing information regarding the use of this medication. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of specific data on geriatric use. Monitoring for potential adverse effects and therapeutic efficacy is advised, as individual responses may vary in this age group.

Pregnancy

There are no specific statements regarding the use of hydrocortisone 1% cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, there are no dosage modifications recommended for individuals who are pregnant. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of this medication during pregnancy.

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 data 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 information necessitates careful clinical judgment and monitoring.

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, and respiratory distress.

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 monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. 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. It is important for patients to be aware that they should discontinue use and consult a doctor if their condition worsens. Additionally, patients should be instructed to stop using the product and seek medical advice if their symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. Patients must be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20º-25ºC (68º-77ºF) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging. Special handling needs include avoiding exposure to extreme temperatures and direct sunlight to preserve the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. Clinicians should advise patients to avoid contact with the eyes and to refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

For patients experiencing external genital, feminine, or anal itching, it is crucial not to exceed the recommended dosage unless directed by a doctor. In the event of bleeding, patients should discontinue use and seek medical advice. Additionally, patients should be cautioned against inserting the product into the rectum using fingers or any mechanical device or applicator.

Drug Information (PDF)

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

View product document (PDF)