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Instant 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)
Marketed in the U.S.
Since 2012
Label revision date
June 19, 2018
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
Marketed in the U.S.
Since 2012
Label revision date
June 19, 2018
Manufacturer
Meijer
Registration number
part348
NDC root
41250-795

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Drug Overview

This medication is designed to provide temporary relief from itching caused by minor skin irritations and rashes. You may find it helpful for specific conditions such as eczema, reactions to poison ivy, oak, and sumac, as well as irritations from cosmetics, jewelry, soaps, detergents, and insect bites.

It's important to use this product as directed, and for any other uses, you should consult with a doctor for guidance.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations and rashes. This includes conditions like eczema, reactions to poison ivy, oak, and sumac, as well as irritations from cosmetics, jewelry, soaps, detergents, and insect bites.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. Make sure to follow this frequency to ensure the best results.

If your child is under 2 years of age, it's important not to use this medication without first consulting a doctor. Always check with a healthcare professional if you have any questions or concerns about using this treatment.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always follow the guidance provided to ensure safe use.

Side Effects

You should be aware that this product is for external use only and is flammable, so keep it away from fire or flames. Avoid getting it in your eyes. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult a doctor before using any other hydrocortisone products. It is not intended for treating diaper rash, and you should also avoid puncturing or incinerating the container, as it is under pressure and should not be stored above 120°F.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. It is flammable, so keep it away from fire or flames. Be careful not to let it come into contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor before trying any other hydrocortisone products.

Do not use this product for diaper rash; please speak with your doctor if you need treatment for that. Remember, the container is under pressure, so do not puncture or incinerate it, and avoid storing it at temperatures above 120°F. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

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, you may be wondering about the safety of using hydrocortisone 1% spray. According to the information available, there are no specific warnings, precautions, or dosage changes required for using this spray during pregnancy. Additionally, the product insert does not indicate that it is contraindicated (not recommended) for pregnant individuals, nor does it mention any risks to the fetus.

While this information suggests that hydrocortisone 1% spray may be safe to use during pregnancy, it is always best to consult with your healthcare provider before starting any new medication. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any medications with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any potential risks are managed effectively. Always prioritize open communication with your doctor about your health and any concerns you may have regarding medications.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions do not address how your kidney health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your kidney health while considering any medications you may need.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While the information provided does not indicate any specific drug interactions or laboratory test interactions, your healthcare provider can help ensure that your treatment plan is safe and effective. Always discuss any new medications or changes in your health with them to avoid potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place where temperatures do not exceed 120°F (49°C). Avoid exposing it to high heat, as this can compromise its integrity. Handle the product with care; do not puncture or incinerate it, as it contains pressurized contents that could be dangerous if mishandled.

Additionally, remember that the product is flammable, so keep it away from any sources of fire or flame. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 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, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the drug used for?

The drug is indicated for the temporary relief of itching associated with minor skin irritation and rashes, including conditions like eczema, poison ivy, and insect bites.

How should I use this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Do not use in children under 2 years of age without consulting a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only, is flammable, and should be kept away from fire. Avoid contact with eyes, and consult a doctor if symptoms persist for more than 7 days.

Can I use this drug during pregnancy?

The insert does not provide specific information regarding the use of this drug during pregnancy, so consult your doctor for advice.

Is it safe to use while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow the drug?

If swallowed, get medical help or contact a Poison Control Center immediately.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

What should I do if my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, stop using the product and consult a doctor.

Packaging Info

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

Packaging configurations for Instant Cooling Itch Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3 in the provided text.

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.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

This product is intended for external use only. It is imperative to keep the product away from fire or flame due to its flammable nature.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients should discontinue use of this product. It is essential that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

This product is not indicated for the treatment of diaper rash; patients should be directed to consult a doctor for appropriate management in such cases.

Additionally, it is crucial to inform patients not to puncture or incinerate the container, as it is under pressure. The product should be stored at temperatures not exceeding 120˚F to maintain its integrity.

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

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. Contact with the eyes should be avoided. 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, patients are advised to discontinue use and consult a doctor before using any other hydrocortisone product.

This product is not recommended for the treatment of diaper rash, and consultation with a healthcare professional is necessary in such cases. Additionally, patients should not puncture or incinerate the container, as it is under pressure. It is crucial to store the product at temperatures not exceeding 120˚F.

Furthermore, this product should 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Instant Cooling Itch Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

Pregnancy

Hydrocortisone 1% spray has not been specifically studied in pregnant patients, and there are no warnings, precautions, or dosage modifications regarding its use during pregnancy mentioned in the prescribing information. The available data does not indicate whether the product is contraindicated in pregnancy or if there are any associated risks to the fetus.

Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. As with any medication, it is advisable to use hydrocortisone 1% spray during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 provided text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a pressurized container, which must not be punctured or incinerated due to the contents being under pressure. It is essential to store the product at temperatures not exceeding 120˚F to maintain its integrity and effectiveness. Additionally, the product is flammable; therefore, it should be kept away from fire or flame to ensure safety during storage and handling.

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. 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 experiences.

Drug Information (PDF)

This file contains official product information for Instant 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 Instant 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.

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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.