Meijer Maximum Strength Anti-Itch Cream Ultra Moisturizing Formula 1oz

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "A" on one side and "1" on the other side. Each tablet contains 1 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes in adults and children aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Additionally, this drug is indicated for the treatment of external anal and genital itching in adults. It is recommended that, when practical, the affected area be cleaned with mild soap and warm water, followed by thorough rinsing. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth before application. Similar to the previous indication, it should be applied no more than 3 to 4 times daily. For children under 12 years of age, a healthcare professional should be consulted before use.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The product should be stored at room temperature, specifically between 20-25ºC (68-77ºF). It is essential to maintain this temperature range to ensure the stability and efficacy of the medication. Healthcare professionals are advised to monitor storage conditions regularly and ensure that the product is not exposed to extreme temperatures. Proper storage is critical for maintaining the integrity of the medication until it is administered to patients.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. It is also contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases. Additionally, the product must not be used in excess of the directed dosage unless specifically instructed by a physician. Direct application into the rectum using fingers, mechanical devices, or applicators is also prohibited.

Warnings and Precautions

For external use only. This product is not intended for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a doctor. Users are cautioned against exceeding the recommended dosage unless specifically directed by a healthcare provider.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. It is important to refrain from using any other hydrocortisone products without consulting a doctor. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a doctor. Rectal bleeding is another serious condition that warrants immediate medical attention.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Maximum Strength Anti-Itch Cream Ultra Moisturizing Formula 1oz (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief 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. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years of age, it is recommended to seek a doctor's advice before using the product.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the need for further medical evaluation. Healthcare providers should remain vigilant and prepared to manage any complications that may occur as a result of overdosage, even in the absence of specific symptoms outlined in the drug insert.

For further management, consultation with a poison control center or a medical toxicologist may be beneficial to guide treatment decisions and ensure optimal patient care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients to adhere strictly to the recommended dosage and to avoid using more than directed unless specifically advised by a doctor. Patients should be made aware that they need to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

Furthermore, patients should be advised to stop using the product and seek medical attention if they experience rectal bleeding. While using this product, it is crucial to avoid contact with the eyes. Patients should also be instructed not to insert the product directly into the rectum using fingers or any mechanical device or applicator.

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 room temperature, maintaining a range of 20-25ºC (68-77ºF). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

For the management of itching associated with skin irritation, inflammation, and rashes, as well as external anal and genital itching, patients aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Meijer Maximum Strength Anti-Itch Cream Ultra Moisturizing Formula 1oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)