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Proheal Hydrocortisone 1% Maximum Strength Plus Aloe

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 25, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 2025
Label revision date
August 25, 2025
Manufacturer
Click Industries LLC
Registration number
M017
NDC root
86173-005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Hydrocortisone 1% Aloe is a topical medication designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. This includes conditions such as eczema, insect bites, and reactions to poison ivy, oak, or sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it can help alleviate external anal and genital itching.

While it is effective for these uses, it's important to consult with a doctor for any other applications of this product to ensure safe and appropriate use.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, insect bites, and reactions to poison ivy, oak, or sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it offers temporary relief for itching in the external anal and genital areas.

For any other uses, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For those experiencing itching in the external anal or genital areas, start by gently cleansing the area with mild soap and warm water, then rinse thoroughly. After that, pat the area dry with toilet tissue or a soft cloth before applying the medication. Again, you can apply it up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please check with a doctor first.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in the genital area if you have a vaginal discharge or for treating diaper rash; consult a doctor in these cases. Be careful to keep it away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. Additionally, do not insert the product into the rectum using fingers or any device.

If you experience rectal bleeding, notice that your condition worsens, or if symptoms persist for more than seven days or return shortly after improvement, stop using the product and consult a doctor. If the product 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 using it on sensitive areas like the genital region if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless directed by your doctor. It's important not to insert the product directly into the rectum using fingers or any devices.

If you experience rectal bleeding, notice that your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency 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 act quickly. You should seek medical help or contact a Poison Control Center right away. This is crucial to ensure safety and receive the appropriate care.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. 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 important to be cautious with any medications, including hydrocortisone cream. The information available does not provide specific details about the safety, dosage adjustments, or any special precautions for using this cream during pregnancy.

Since there is a lack of clear guidance, it's best to consult with your healthcare provider before using hydrocortisone cream. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize your health and the health of your baby when considering any treatment.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. Currently, there is no information indicating that this cream is passed into breast milk or that it poses any risks to your infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about its use while nursing.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For issues related to itching in the external anal or genital areas, you should also consult a doctor if your child is under 12 years old. Always prioritize your child's safety and seek professional advice when needed.

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, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

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 function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

For treating itching caused by skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, you should consult a doctor before use.

If you are dealing with itching in the external anal or genital area, it's best to first clean the area with mild soap and warm water, then gently dry it before applying the medication. Again, you can apply it up to 3 to 4 times daily, but if the patient is under 12 years old, consult a doctor for guidance.

FAQ

What is Hydrocortisone 1% Aloe used for?

Hydrocortisone 1% Aloe temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I use Hydrocortisone 1% Aloe?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any warnings for using this product?

Yes, it is for external use only. Avoid contact with eyes, and do not use in the genital area if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if I accidentally swallow Hydrocortisone 1% Aloe?

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

Can I use Hydrocortisone 1% Aloe during pregnancy or while nursing?

There is no specific information regarding the use of Hydrocortisone 1% Aloe during pregnancy or nursing in the provided text, so consult your doctor for advice.

What should I do if my condition worsens or does not improve?

Stop using the product and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

How should I store Hydrocortisone 1% Aloe?

Store the product at 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Proheal Hydrocortisone 1% Maximum Strength Plus Aloe.
Details

Drug Information (PDF)

This file contains official product information for Proheal Hydrocortisone 1% Maximum Strength Plus Aloe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it provides temporary relief for external anal and external genital itching.

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

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a physician is advised.

In cases of external anal and external genital itching in adults, it is advisable to first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

When administering this product, it is imperative to avoid contact with the eyes. Patients should be instructed not to exceed the recommended dosage unless directed by a physician. Furthermore, the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Patients must be advised to discontinue use and seek medical advice if rectal bleeding occurs. If the condition worsens, or if symptoms persist for more than seven days or resolve only to recur within a few days, patients should refrain from using this or any other hydrocortisone product without consulting a healthcare professional.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients should consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and seek medical advice if rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not use this or any other hydrocortisone product without consulting a doctor.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Proheal Hydrocortisone 1% Maximum Strength Plus Aloe (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proheal Hydrocortisone 1% Maximum Strength Plus Aloe.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and external genital itching, pediatric patients under 12 years of age should also seek medical advice before use.

Geriatric Use

There is no specific information available 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 is no specific information available regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if appropriate.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Healthcare providers are encouraged to follow established protocols for the treatment of overdosage, which may include supportive care and symptomatic treatment as necessary.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of children.

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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

For the management of itching associated with skin irritation, inflammation, and rashes, adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and external genital itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, a doctor's consultation is also recommended.

Drug Information (PDF)

This file contains official product information for Proheal Hydrocortisone 1% Maximum Strength Plus Aloe, 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 Proheal Hydrocortisone 1% Maximum Strength Plus Aloe, 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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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.