Maximum Strength Hydrocortisone Plus Moisturizing Aloe

Description

Aramark's product consists of hydrocortisone, formulated as a maximum strength anti-itch analgesic, designed for the temporary relief of minor skin irritations. Each packet contains 1 gram of hydrocortisone, with a total of 25 packets per unit. The formulation is enhanced with moisturizing aloe. This product is comparable to other hydrocortisone formulations at a concentration of 1%. It is manufactured by Aramark, located in Lenexa, KS 66219. For further information, the company can be contacted at (913) 269-9611 or through their website at aramarkuniform.com.

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, jewelry, seborrheic dermatitis, psoriasis, and scrapes. Additionally, it is indicated for the relief of external genital, feminine, and anal 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 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, adults experiencing external anal itching are advised to cleanse the affected area with mild soap and 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.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is essential to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in patients who are concurrently using any other hydrocortisone product without prior consultation with a healthcare professional. This precaution is necessary to avoid potential adverse effects associated with combined hydrocortisone therapies.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be introduced into the rectum using fingers, mechanical devices, or applicators. Prior to use, individuals should consult a healthcare professional if they experience vaginal discharge associated with external feminine itching.

When addressing external itching, it is crucial not to exceed the recommended daily dosage. Should any bleeding occur, or if the condition worsens, it is advised to seek medical consultation. If symptoms persist for more than 7 days, or if they resolve and then recur within a few days, individuals should consult a doctor, particularly if they are concurrently using any other hydrocortisone products.

General precautions include refraining from the use of this product in conjunction with any other hydrocortisone formulations unless a healthcare provider has been consulted.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should be vigilant and consult a healthcare professional if they experience vaginal discharge related to external feminine itching, or if their condition worsens or persists beyond the specified duration.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes. Additionally, it is crucial that patients do not insert this product into the rectum using fingers, mechanical devices, or applicators.

Before using this product, patients should consult a doctor if they have a vaginal discharge associated with external feminine itching. For those experiencing external itching, it is advised not to exceed the recommended daily dosage. Patients should seek medical advice if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. Furthermore, if symptoms clear up and then recur within a few days, consultation with a healthcare provider is recommended. Patients are also advised to ask a doctor before use if they are currently using any other hydrocortisone product.

Drug Interactions

Concurrent use of hydrocortisone with other hydrocortisone-containing products is not recommended unless a healthcare professional has been consulted. This precaution is essential to avoid potential additive effects and complications associated with excessive corticosteroid exposure.

Patients are advised to seek medical advice prior to initiating treatment with hydrocortisone if they are currently using any other hydrocortisone formulations. This ensures appropriate management and monitoring of potential interactions and adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Hydrocortisone Plus Moisturizing Aloe (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 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and a healthcare professional should be consulted. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use.

It is important to keep this medication 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 recommended.

Geriatric Use

There is no specific information 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.

Pregnancy

Pregnant patients should not use this product unless directed by a healthcare professional. It is essential for women who are pregnant or planning to become pregnant to consult their doctor prior to use. The potential risks and benefits must be carefully evaluated in the context of individual circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, patients should be informed not to use this medication in conjunction with any other hydrocortisone products unless they have consulted with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature between 15° to 30° C (59° to 86° F). It is crucial to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)