Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Anti-Itch Paraben Free

Last content change checked dailysee data sync status

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 2023
Label revision date
December 12, 2023
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 2023
Label revision date
December 12, 2023
Manufacturer
Weeks & Leo Co. , Inc.
Registration number
M017
NDC root
11383-313
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 Cream 1% with Aloe Vera is a topical medication designed to provide temporary relief from itching associated with various minor skin irritations, inflammation, and rashes. It can help soothe itching caused by conditions such as eczema, seborrheic dermatitis, and psoriasis, as well as reactions to insect bites, poison ivy, poison oak, and poison sumac. Additionally, it can alleviate itching related to cosmetics, jewelry, detergents, and soaps, and it offers temporary relief for external anal and genital itching.

This cream works by reducing inflammation and calming the skin, making it a helpful option for managing discomfort from these common skin issues. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

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, seborrheic dermatitis, and psoriasis. It’s also effective for soothing itching from insect bites and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, if you experience irritation from cosmetics, jewelry, detergents, or soaps, this product may help alleviate that discomfort.

Moreover, it can temporarily relieve itching in external anal and genital areas. For any other uses, it’s important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you or your child are experiencing external anal itching, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it's important to consult a doctor before using this treatment.

Before applying the medication, make sure to clean the affected area. You can do this by using mild soap and warm water, rinsing thoroughly, or by gently patting with a suitable cleansing pad. After cleaning, gently dry the area by patting or blotting with toilet tissue or a soft cloth. If the affected person is a child under 12 years, please consult a doctor for guidance on treatment.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash, external genital itching with vaginal discharge, or external anal itching if you experience rectal bleeding—always consult a doctor in these cases.

While using this product, avoid getting it in your eyes. For external anal itching, do not exceed the recommended dosage unless directed by a doctor. Additionally, never insert the product into the rectum using your fingers or any device. 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. Avoid getting it in your eyes, and if you're treating external anal itching, do not exceed the recommended amount unless directed by a doctor. You should not use this product for diaper rash or if you have vaginal discharge or rectal bleeding; in these cases, consult a doctor.

If your condition worsens, symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor. Always keep this product 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 getting it in your eyes. If you're using it for external anal itching, follow the directions carefully and do not exceed the recommended amount unless your doctor advises otherwise. It's important not to insert the product into the rectum using fingers or any devices.

You should not use this product for diaper rash or for external genital itching if you have a vaginal discharge. If you experience rectal bleeding while using it for anal itching, consult your doctor immediately. If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and contact your doctor.

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 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

When it comes to using hydrocortisone cream during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing any risk to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before 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 12 years old and is experiencing external anal itching, you should also seek advice from a doctor. Always prioritize your child's safety and well-being by following these guidelines.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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 (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

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

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

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 the patient is under 2 years old, consult a doctor before use. For adults experiencing external anal itching, it's recommended to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If the patient is a child under 12 years old, you should also consult a doctor for guidance.

FAQ

What is Hydrocortisone Cream 1% with Aloe Vera used for?

It is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream relieve itching from?

It can relieve itching due to eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, poison oak, cosmetics, jewelry, detergents, soaps, and temporarily relieve external anal and genital itching.

How should I apply Hydrocortisone Cream?

Adults and children 2 years and over should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings when using this product?

Yes, do not get it into your eyes, and do not use it for diaper rash, external genital itching with vaginal discharge, or external anal itching if rectal bleeding occurs without consulting a doctor.

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

Stop use and consult your doctor if your condition gets worse, if symptoms last for more than 7 days, or if they clear up and occur again within a few days.

How should I store Hydrocortisone Cream?

Store it at 20 °C to 25 °C (68 °F to 77 °F).

Is it safe to use Hydrocortisone Cream during pregnancy or while nursing?

There is no specific information provided regarding its use during pregnancy or lactation, so consult your doctor for advice.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Packaging Info

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

Packaging configurations for Anti-Itch Paraben Free.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Cream 1% with Aloe Vera is a topical formulation containing hydrocortisone as the active ingredient at a concentration of 1%. This cream is designed for dermatological use and incorporates aloe vera, known for its soothing properties. The formulation is intended to provide anti-inflammatory effects and alleviate skin irritation. The cream is typically presented in a smooth, emollient base, facilitating easy application and absorption into the skin.

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, poison oak, and poison sumac. It is also effective for itching related to cosmetics, jewelry, detergents, and soaps. Additionally, this drug provides temporary relief for external anal and 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

Adults and children aged 2 years and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

In cases of external anal itching in adults, it is advisable to cleanse the affected area with mild soap and warm water when practical, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before the application of the medication.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised. It should not be used for external genital itching in the presence of vaginal discharge; a doctor should be consulted. Additionally, the product is contraindicated for external anal itching if rectal bleeding occurs; prompt medical consultation is necessary.

When using this product, it must not come into contact with the eyes. For external anal itching, do not exceed the directed dosage unless instructed by a healthcare professional. The product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. In cases of external anal itching, the product should not be used in excess of the directed dosage unless specifically instructed by a healthcare professional. Additionally, the product must not be inserted into the rectum using fingers, mechanical devices, or applicators.

This product is contraindicated for the treatment of diaper rash; consultation with a healthcare provider is advised in such instances. It should also not be used for external genital itching if there is a presence of vaginal discharge, nor for external anal itching if rectal bleeding occurs. In these situations, prompt medical consultation is necessary.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. Patients should refrain from initiating the use of any other hydrocortisone products without prior consultation.

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 that this product is for external use only. It is important to avoid contact with the eyes during application. For individuals experiencing external anal itching, it is advised not to exceed the directed dosage unless specifically instructed by a healthcare professional. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical devices or applicators.

This product is not indicated for the treatment of diaper rash; patients should consult a doctor for such conditions. It is also contraindicated for use in cases of external genital itching accompanied by vaginal discharge, and for external anal itching if rectal bleeding occurs. In these instances, prompt consultation with a healthcare provider is recommended.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is also important not to initiate the use of any other hydrocortisone products without consulting a healthcare professional.

To ensure safety, 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.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Anti-Itch Paraben Free.
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 no more than 3 to 4 times daily. In cases of external anal itching in children under 12 years, it is advised to seek guidance from a healthcare provider.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

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

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 drug insert 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 specific guidance necessitates careful clinical judgment and monitoring of these patients.

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 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 provided in the insert.

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 inform patients that this product is intended for the treatment of diaper rash, and they should consult a doctor for further guidance.

Patients experiencing external genital itching accompanied by vaginal discharge should also be encouraged to seek medical advice. Similarly, if patients have external anal itching and notice rectal bleeding, they should consult a doctor promptly.

Healthcare providers should instruct patients to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or resolve only to recur within a few days, patients should refrain from using any other hydrocortisone products and consult their healthcare provider.

Patients must be cautioned against getting the product into their eyes. For those using it for external anal itching, it is crucial to adhere strictly to the directed dosage and not exceed it unless specifically instructed by a doctor. Additionally, patients should be informed that the product should not be inserted into the rectum using fingers or any mechanical device or applicator.

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 °C to 25 °C (68 °F to 77 °F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity of the product.

Additional Clinical Information

The medication is administered topically, with specific guidelines for different age groups. 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, consultation with a doctor is advised prior to use. In adults experiencing external anal itching, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years with external anal itching, a doctor's advice is also necessary.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Anti-Itch Paraben Free, 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 Anti-Itch Paraben Free, 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

Last AI update:

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.