Hydrocortisone

Description

The Anti-Itch Spray is a topical formulation designed to alleviate itching. It is presented in an image/jpeg format for reference, with the effective time noted as November 8, 2018. The reference value for the product is designated as 6070-WG-US-Rev1-Anti-Itch Spray-HighRes.jpg.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation and rashes due to various conditions, including eczema, poison ivy, oak, and sumac exposure, as well as reactions to cosmetics, jewelry, soaps, detergents, and insect bites.

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

The recommended dosage of the anti-itch spray is to apply it topically to the affected area. The application should be performed as needed, ensuring that the spray is evenly distributed over the skin surface.

Healthcare professionals should instruct patients to use the spray no more than four times per day. Prior to application, it is advisable to clean the affected area gently and allow it to dry. The spray should be held approximately 6 to 8 inches away from the skin during application to ensure proper coverage and minimize the risk of irritation.

In cases where symptoms persist or worsen after the initial treatment period, patients should be advised to consult a healthcare provider for further evaluation and management.

Contraindications

Use is contraindicated in the following situations:

• Application in or near the eyes is prohibited due to the potential for irritation or damage to ocular tissues.

• The product should not be used for external genital, vaginal, or anal itching, as it may not be appropriate for these sensitive areas.

• Use for diaper rash is contraindicated unless directed by a healthcare professional, to ensure safety and appropriateness of treatment.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

This product is contraindicated for use in or near the eyes, as well as for external genital, vaginal, or anal itching, and for diaper rash. In such cases, consultation with a healthcare professional is advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or fails to improve within 7 days; symptoms persist beyond 7 days; or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective treatment.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens or does not improve within 7 days. Additionally, if symptoms persist for more than 7 days or clear up and then occur again within a few days, medical advice should be sought.

Drug Interactions

The concurrent use of hydrocortisone with other hydrocortisone products is not recommended unless a healthcare professional has been consulted. This precaution is essential to avoid potential additive effects and complications associated with corticosteroid therapy.

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 necessary unless otherwise indicated by clinical judgment.

Packaging & NDC

Below are the non-prescription pack sizes of Cooling Itch Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely, and the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. This product is not indicated for the treatment of diaper rash; consultation with a healthcare professional is advised for appropriate management in such cases.

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, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Cooling Itch Relief Spray during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals are advised to exercise caution and consider the absence of data when discussing the use of this product with women of childbearing potential.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most effective management strategies tailored to the individual case.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are paramount in managing potential overdose situations.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to emphasize the necessity of keeping the product out of the eyes; if contact occurs, patients should rinse the affected area with water to ensure proper removal.

Patients should be instructed to use the product only as directed to avoid any potential misuse. Additionally, healthcare providers should inform patients not to puncture or incinerate the container, as it is under pressure. It is also crucial to advise patients against storing the product at temperatures exceeding 120°F to maintain its integrity and safety.

Storage and Handling

The product is supplied in a configuration that includes specific National Drug Code (NDC) numbers, which are essential for identification and inventory management.

For optimal storage, it is crucial to maintain the product at temperatures not exceeding 120°F. It is imperative to avoid puncturing or incinerating the container, as the contents are under pressure and may pose safety risks if mishandled. Proper handling and adherence to these storage conditions will ensure the integrity and safety of the product.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to keep the medication out of the eyes and to rinse with water if contact occurs. It is important for patients to use the product only as directed and to avoid puncturing or incinerating the container, as it is under pressure. Storage should not exceed temperatures of 120˚F. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)