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Cooling Itch Relief

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
June 12, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
June 12, 2018
Manufacturer
Rite Aid
Registration number
part348
NDC root
11822-1223
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve itching caused by minor skin irritations and rashes. It can be helpful for various conditions, including eczema, poison ivy, oak, and sumac reactions, as well as irritations from cosmetics, soaps, detergents, jewelry, insect bites, and seborrheic dermatitis.

By targeting the discomfort associated with these skin issues, this drug aims to provide you with relief and improve your comfort during flare-ups.

Uses

If you're dealing with minor skin irritations or rashes, this medication can help provide temporary relief from itching. It's effective for various conditions, including eczema, poison ivy, oak, and sumac reactions, as well as irritations caused by cosmetics, psoriasis, soaps, detergents, jewelry, insect bites, and seborrheic dermatitis.

You can use this treatment to soothe your skin and alleviate discomfort associated with these common irritants. Remember, it’s designed for temporary relief, so if your symptoms persist, consider consulting a healthcare professional.

Dosage and Administration

If you or your child is 2 years of age or older, you can apply the medication directly to the affected area of the skin. It’s important to do this no more than 3 to 4 times a day to ensure safety and effectiveness.

For children under 2 years old, it’s best to consult with a doctor before using the medication. This will help ensure that it’s appropriate and safe for their specific needs. Always follow these guidelines to get the best results from your treatment.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never use it in or near your eyes, and if you're considering it for diaper rash, please consult a doctor first. Always follow the instructions provided and use the product only as directed.

Additionally, be cautious when handling the product. Keep it away from your eyes and rinse with water if contact occurs. Do not puncture or incinerate the container, as it is under pressure, and avoid storing it at temperatures above 120°F. Following these guidelines will help ensure your safety and the effective use of the product.

Side Effects

This product is for external use only and should not be applied near your eyes or used for diaper rash without consulting a doctor. It's important to keep it away from heat, flames, and smoking areas, as it is flammable. When using this product, make sure to follow the directions carefully and avoid puncturing or incinerating the container, as it is under pressure.

If your condition worsens or does not improve within 7 days, or if symptoms persist for more than a week or return shortly after clearing up, stop using the product and consult a doctor. Additionally, keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes or for diaper rash unless directed by a doctor. It is also flammable, so do not use it while smoking or near any heat sources or flames. When applying, make sure to keep it away from your eyes; if it does get in your eyes, rinse them with water immediately. Always use the product as directed, and remember not to puncture or incinerate the container, as it is under pressure. Store it in a cool place, below 120°F.

Before using this product, consult your doctor if you are already using any other hydrocortisone products. If your condition worsens or does not improve within 7 days, or if your symptoms persist for more than 7 days or return shortly after clearing up, stop using the product and contact your doctor. Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's reassuring to know that there are no specific warnings, precautions, or contraindications related to the use of COOLING ITCH RELIEF RITE AID - hydrocortisone 1% spray mentioned in the drug insert. This means that, based on the available information, it is generally considered safe for use during pregnancy.

However, it's always a good idea to consult with your healthcare provider before using any medication, including over-the-counter products, to ensure it is appropriate for your individual situation. Your healthcare provider can offer personalized advice and address any concerns you may have.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are already using any other hydrocortisone products. Combining different hydrocortisone treatments can lead to unexpected side effects or reduce the effectiveness of your treatment. Always keep your doctor informed about all the medications and products you are using to ensure your safety and the best possible care.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place where the temperature does not exceed 120°F. It's important to keep the product out of reach of children to prevent any accidental misuse. Handle the product carefully; do not puncture or incinerate it, as the contents are under pressure and could pose a safety risk if mishandled.

Always remember to follow these guidelines to maintain the integrity of the product and ensure your safety. Proper storage and handling are key to using the product effectively.

Additional Information

You can apply this medication to the affected area of your skin up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What conditions can this drug help relieve?

This drug temporarily relieves itching associated with minor skin irritation and rashes due to conditions like eczema, poison ivy, cosmetics, psoriasis, soaps, jewelry, insect bites, and seborrheic dermatitis.

How should I use this drug?

For adults and children 2 years and older, apply to the affected area no more than 3 to 4 times daily. Children under 2 years should ask a doctor before use.

Are there any contraindications for using this drug?

Do not use this drug in or near the eyes or for diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or does not improve within 7 days, or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or while nursing?

There are no specific warnings or contraindications regarding pregnancy or nursing mentioned for this product.

What precautions should I take when using this product?

Keep the product out of your eyes, use only as directed, and do not puncture or incinerate the container. Also, do not store it above 120°F.

What should I do if this product is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Is this product flammable?

Yes, this product is flammable. Do not use it while smoking or near heat or flame.

Packaging Info

Below are the non-prescription pack sizes of Cooling Itch Relief (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cooling Itch Relief.
Details

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)

Description

No relevant information is available for SPL code 34089-3.

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, cosmetics, psoriasis, soaps and detergents, jewelry, insect bites, and seborrheic dermatitis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area, not exceeding 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied in or near the eyes due to the potential for irritation or injury. Additionally, it is contraindicated for use on diaper rash unless a healthcare professional has been consulted, as this may pose risks that require medical evaluation.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or open flame.

The product should not be applied in or near the eyes, and it is contraindicated for use on diaper rash unless directed by a physician. When using this product, it is imperative to keep it out of the eyes; in the event of contact, rinse thoroughly with water. Users must adhere strictly to the directions provided. The container should not be punctured or incinerated, as it is under pressure. Additionally, it should not be stored at temperatures exceeding 120°F.

Prior to use, patients should consult a healthcare professional if they are currently using any other hydrocortisone products. Users are advised to discontinue use and seek medical advice if the condition worsens or fails to improve within 7 days, or if symptoms persist beyond 7 days or resolve only to recur within a few days.

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 is recommended.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. The product should not be applied in or near the eyes, nor should it be used for diaper rash unless directed by a doctor.

When using this product, patients must take care to keep it out of the eyes and rinse with water if contact occurs. It is essential to use the product only as directed, avoiding any actions that could compromise safety, such as puncturing or incinerating the container, which is under pressure. Additionally, the product should not be stored at temperatures exceeding 120°F.

Patients are advised to consult a doctor before using this product if they are currently using any other hydrocortisone product. They should discontinue use and seek medical advice if their condition worsens or does not improve within 7 days, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

The concomitant use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult their healthcare provider prior to initiating treatment with hydrocortisone if they are currently using any other hydrocortisone formulations. This is to prevent potential additive effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cooling Itch Relief (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cooling Itch Relief.
Details

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, not exceeding 3 to 4 times daily.

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

Pregnancy

There are no specific warnings, precautions, or contraindications regarding pregnancy associated with the use of COOLING ITCH RELIEF RITE AID - hydrocortisone 1% spray. Available data does not indicate any known risks to pregnant patients or potential adverse fetal outcomes. However, as with any medication, healthcare professionals should consider the benefits and risks when prescribing this product to pregnant patients. It is advisable for women of childbearing potential to consult with their healthcare provider before using this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risk to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data may necessitate individualized assessment and monitoring based on clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 fully evaluate the nonclinical toxicology profile.

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 instruct patients not to use the product in or near the eyes, and to keep it out of the eyes during application. If patients are using the product for diaper rash, they should be encouraged to consult a doctor for guidance.

Patients should be informed to discontinue use and consult a healthcare professional if their condition worsens or does not improve within 7 days. Additionally, they should be advised to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

When discussing the product's usage, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned against puncturing or incinerating the container, as it is under pressure. They should also be informed not to store the product at temperatures exceeding 120°F.

Finally, healthcare providers should recommend that patients consult their doctor before using this product if they are currently using any other hydrocortisone products.

Storage and Handling

The product is supplied in a container that is under pressure. It is essential to store the product in a location where the temperature does not exceed 120°F. Care should be taken to keep the product out of reach of children to ensure safety. Additionally, the container should not be punctured or incinerated to prevent any hazardous situations. Proper handling and storage conditions are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied 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 doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Cooling Itch Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.