H Plus Holdings

Description

Hair Sanity Anti-Itch Shampoo Step 1 is presented in a 3 fluid ounce dosage form. This product is designed to alleviate itching associated with scalp conditions. The formulation is intended for topical application to the hair and scalp.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes.

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

Dosage and Administration

For application, a quarter-sized amount of the product should be applied to the top of the head, followed by another quarter-sized amount to the sides of wet hair and scalp. To enhance lather, additional water and cleanser may be added as needed. The lather should be massaged into the scalp and rinsed thoroughly with warm water.

The product is intended for use daily or at a minimum frequency of three times per week. It is contraindicated for use in children under 2 years of age; consultation with a doctor is advised in such cases.

The product should be stored at room temperature to maintain its efficacy.

Contraindications

Use of this product is contraindicated in patients who experience worsening of their condition or persistence of symptoms for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, discontinuation of this product is advised. Reinitiation of any hydrocortisone product should only occur after consultation with a healthcare professional.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

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

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should another hydrocortisone product be initiated without prior consultation with a doctor.

Side Effects

For external use only. Patients should be advised that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, they should discontinue use of this product. It is important that patients do not begin use of any other hydrocortisone product without first consulting a doctor.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the medication. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals should continue to assess the patient's overall medication regimen and clinical status to ensure safe and effective use of the medication.

Packaging & NDC

Below are the non-prescription pack sizes of H Plus Holdings (hydrocortisone acetate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. It is essential to keep the product 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.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone acetate during pregnancy has not been established. The use of this product is not recommended during pregnancy unless directed by a healthcare provider. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a doctor before use.

Dosage adjustments may be necessary, and healthcare professionals should be consulted for guidance on appropriate dosing. Pregnant women should use this product only if the benefits outweigh the risks and under medical supervision.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management 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 safety profile 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 product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned to avoid contact with the eyes while using this product. It is important for healthcare providers to emphasize that if the patient's 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 of the product. Patients should be advised not to begin use of any other hydrocortisone product without first consulting a doctor.

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 to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is intended for topical administration, with a recommended usage of daily application or at least three times per week. Clinicians should advise patients that the product is for external use only and to avoid contact with the eyes. Patients are instructed to discontinue use if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. In such cases, consultation with a healthcare provider is necessary before using any other hydrocortisone products. Additionally, the product should be kept out of reach of children, and immediate medical assistance or contact with a Poison Control Center is advised if ingested.

Drug Information (PDF)

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

View product document (PDF)