Barmicil Anti-Itch

Description

Barmicil® Plus is a maximum strength anti-itch cream formulated with 1% hydrocortisone and aloe vera. This topical preparation is designed to provide effective relief from itching and irritation. The product is available in a net weight of 1 oz (28 g).

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 eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, poison oak, and poison sumac. It is also indicated for itching related to cosmetics, jewelry, detergents, and soaps. Additionally, this drug provides temporary relief of external anal and genital itching.

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

Dosage and Administration

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 anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water when practical, 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 the application of the medication.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

The product is contraindicated in the following situations:

• The treatment of diaper rash is not recommended; consult a healthcare professional for appropriate alternatives.

• Use is contraindicated for external genital itching in the presence of vaginal discharge; a healthcare professional should be consulted.

• External anal itching treatment is contraindicated if rectal bleeding occurs; prompt consultation with a healthcare professional is advised.

• Contact with the eyes must be avoided to prevent irritation or injury.

• For external anal itching, do not exceed the directed dosage unless specifically instructed by a healthcare professional.

• The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for external genital itching if accompanied by vaginal discharge, nor for external anal itching in the presence of rectal bleeding. In these situations, prompt medical consultation is recommended.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. It is important to note that patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and patients should consult a doctor if they have external genital itching accompanied by vaginal discharge or if they experience external anal itching with rectal bleeding.

During the use of this product, patients are advised to avoid contact with the eyes. For those using it for external anal itching, it is important not to exceed the directed dosage unless instructed by a healthcare professional. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is also recommended that patients do not initiate the use of any other hydrocortisone product without medical advice.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Barmicil Anti-Itch (hydrocortisone). 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 aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. In cases of external anal itching in children under 12 years, it is advised to seek guidance from a healthcare provider.

Geriatric Use

There is no specific information available 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

There is no specific information available regarding the use of Barmicil Anti-Itch (hydrocortisone cream) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to consult with a healthcare provider for individualized assessment and recommendations.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product is intended for the treatment of diaper rash, and they should consult a doctor for further guidance.

Healthcare providers should discuss with patients the appropriate use of the product for external genital itching, particularly if they experience vaginal discharge, and recommend consulting a doctor in such cases. Similarly, for external anal itching, patients should be instructed to consult a doctor promptly if rectal bleeding occurs.

Patients should be made aware that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use and consult a healthcare professional. It is crucial to inform patients not to use any other hydrocortisone product without medical advice.

Additionally, patients should be cautioned against getting the product into their eyes and should be instructed to use it for external anal itching only as directed, unless otherwise advised by a doctor. They should also be informed that the product should not be inserted 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 upon request. It is essential to store the product at a controlled temperature range of 20 °C to 25 °C (68 °F to 77 °F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any potential degradation of the product during storage and transportation.

Additional Clinical Information

The medication is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years, consultation with a doctor is advised prior to use. In cases of external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years experiencing external anal itching, a doctor's advice is also necessary.

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 Barmicil Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)