Winco Hydrocortisone

Description

WINCO NDC 67091-055-28 is a maximum strength hydrocortisone cream formulated with aloe. Each gram of the cream contains 1% hydrocortisone. The product is presented in a net weight of 1 ounce (28 grams).

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, insect bites, poison ivy, poison oak, poison sumac, 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.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Contraindications

The use of this product is contraindicated in the following situations:

• Treatment of diaper rash is not recommended; consultation with a doctor is advised.

• External genital itching should not be treated if there is a vaginal discharge; a doctor should be consulted.

• Initiation of any other hydrocortisone product should only occur after consulting a doctor.

• Exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless directed by a doctor.

• The product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens. Additionally, if symptoms persist for more than 7 days or if there is a recurrence of symptoms after they have cleared, patients should refrain from using this product and should not initiate the use of any other hydrocortisone product unless specifically directed by a healthcare provider.

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 occur again within a few days. In such cases, patients are advised not to begin use of any other hydrocortisone product unless directed by a healthcare professional.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

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 Winco Hydrocortisone (hydrocortisone 1%). 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. It is important to note that this product is not indicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

If the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the patient should discontinue use and seek medical advice.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Hydrocortisone 1% cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. Additionally, there are no special considerations outlined for women of childbearing potential. As with any medication, healthcare professionals should weigh the benefits against potential risks when prescribing hydrocortisone 1% cream to pregnant individuals.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or toxicology expert is recommended for guidance on the appropriate management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

For patients using the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Similarly, if patients experience external genital itching accompanied by vaginal discharge, they should be instructed to consult a healthcare professional.

Patients should be informed that if their condition worsens or if symptoms persist for more than 7 days, they should discontinue use of the product. They should also be cautioned against using any other hydrocortisone products unless directed by a doctor, especially if symptoms clear up and then recur within a few days.

Healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. Additionally, patients should not exceed the recommended daily dosage for external genital, feminine, and anal itching unless specifically directed by a healthcare provider. In the event of bleeding, patients should be advised to stop use and consult a doctor.

Finally, it is crucial to inform patients that this product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

This product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. It is essential to keep this and all medications out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)