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Maximum Strength Anti-Itch

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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 2014
Label revision date
June 18, 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 2014
Label revision date
June 18, 2018
Manufacturer
Quality Choice
Registration number
part348
NDC root
63868-782
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 (a skin condition that causes scaly patches and red skin).

By targeting the discomfort associated with these skin issues, this drug aims to provide you with relief and improve your comfort. If you're experiencing itching from any of the mentioned conditions, this medication may be a suitable option to consider.

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

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. For children under 2 years of age, it’s important to consult a doctor before use.

When applying the medication to your face, spray it into the palm of your hand first, then gently apply it to the affected area. This method helps ensure that the medication is applied safely and effectively.

What to Avoid

It's important to use this product safely. Do not use it for treating diaper rash; instead, consult your doctor for appropriate options. Avoid contact with your eyes, and if your condition worsens or symptoms persist for more than 7 days, stop using the product. If symptoms clear up and then return within a few days, do not use any other hydrocortisone product without consulting your doctor first.

Additionally, please do not puncture or incinerate the container, as it is under pressure. Store the product in a cool place, ensuring it does not exceed 120°F. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only and should be kept away from children. Avoid contact with your eyes, and if your condition worsens or does not improve after 7 days, stop using it and consult a doctor before trying any other hydrocortisone products. This product is flammable, so do not use it while smoking or near heat or flames.

If swallowed, seek medical help immediately or contact a Poison Control Center. Additionally, do not puncture or incinerate the container, and store it at temperatures below 120°F.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended. It is flammable, which means you should not use it while smoking or near any heat sources or flames. Be careful to keep it away from 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 your doctor before trying any other hydrocortisone products. Additionally, do not use this product for diaper rash; instead, seek advice from a healthcare professional.

If you accidentally swallow this product, it’s important to get medical help immediately or contact a Poison Control Center. Remember, do not puncture or incinerate the container, as it is under pressure, and avoid storing it at temperatures above 120°F.

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 get checked by a medical professional.

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 state 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, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk (meaning whether it passes into your milk) or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any product while breastfeeding. Your health and the health of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use. Always remember to keep the medication out of reach of children to ensure their safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney 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 differently due to your liver health.

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

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 treatments 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 temperatures do not exceed 120°F (49°C). Keeping it within this temperature range helps maintain its integrity and performance.

When handling the product, please remember not to puncture or incinerate it, as the contents are under pressure. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin (topical use) and apply it to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. For children under 2 years, consult a doctor before use. When applying to the face, spray the product into your palm first and then gently apply it.

Remember, this product is for external use only and is flammable, so avoid using it while smoking or near heat and flames. Keep it away from your eyes, and if your condition worsens or symptoms last more than 7 days, stop using it and consult a doctor before trying any other hydrocortisone products. Do not use it for diaper rash, and ensure it is stored safely out of reach of children. If swallowed, seek medical help immediately.

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. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, avoid contact with the eyes, do not use for diaper rash, and do not puncture or incinerate the container. Keep out of reach of children.

Can I use this drug during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy mentioned in the provided information.

What should I do if I accidentally swallow this drug?

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

Is this drug flammable?

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

What should I do if my symptoms persist?

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

Packaging Info

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

Packaging configurations for Maximum Strength Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength Anti-Itch, 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

Healthcare professionals should instruct patients to shake the product well before use. 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.

When applying the product to the face, it is recommended to spray the solution into the palm of the hand and then gently apply it to the desired area.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a doctor is advised in such cases.

Contact with the eyes must be avoided due to potential irritation. If the condition worsens, or if symptoms persist for more than 7 days or resolve and recur within a few days, discontinue use and consult a doctor before using any other hydrocortisone product.

Additionally, the product should not be punctured or incinerated, as it contains pressurized contents. Storage at temperatures exceeding 120˚F is also contraindicated.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should not be used while smoking or in proximity to heat or open flames.

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 7 days, or if symptoms resolve and then recur within a few days, patients should discontinue use of this product. It is imperative that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider. Additionally, this product is not indicated for the treatment of diaper rash; consultation with a physician is recommended in such cases.

The product should not be punctured or incinerated, as it is under pressure. Storage conditions must be monitored closely; it should not be kept at temperatures exceeding 120˚F.

In the case 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. This product is for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame.

When using this product, patients should avoid contact with the eyes. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to discontinue use and consult a doctor before starting any other hydrocortisone product. This product is not intended for the treatment of diaper rash, and consultation with a healthcare professional is recommended 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.

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 should be made right away.

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 Maximum Strength Anti-Itch (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Anti-Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use. Additionally, the product should be kept out of reach of children to ensure safety.

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

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

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

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 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 prescribing 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 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.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should inform patients that if their 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 cautioned against starting any other hydrocortisone product without first consulting a doctor.

Additionally, patients must be made aware that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate treatment options in such cases.

Patients should be instructed not to puncture or incinerate the container, as it is under pressure. Furthermore, it is essential to advise patients to store the product at temperatures not exceeding 120˚F to maintain its efficacy and safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a controlled environment, ensuring that temperatures do not exceed 120˚F.

Special handling precautions must be observed, as the contents are under pressure. Therefore, it is imperative not to puncture or incinerate the container to maintain safety and integrity. Proper adherence to these storage and handling guidelines is essential for optimal product performance and safety.

Additional Clinical Information

The product 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, consultation with a doctor is advised. When applying to the face, it should be sprayed into the palm of the hand before gentle application.

Clinicians should counsel patients that the product is for external use only and is flammable; it should not be used while smoking or near heat or flame. Patients must avoid contact with the eyes and should discontinue use if the condition worsens or if symptoms persist beyond 7 days, unless directed by a doctor. The product is not intended for diaper rash treatment, and patients should consult a doctor if using any other hydrocortisone products. It is crucial to keep the product out of reach of children, and in case of ingestion, medical assistance or contact with a Poison Control Center is necessary. Additionally, the product should not be punctured or incinerated, and should be stored at temperatures below 120˚F.

Drug Information (PDF)

This file contains official product information for Maximum Strength Anti-Itch, 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 Maximum Strength Anti-Itch, 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.