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Quatriderm Anti-Itch

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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 2019
Label revision date
December 4, 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 2019
Label revision date
December 4, 2023
Manufacturer
OPMX LLC
Registration number
M017
NDC root
69729-269
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

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 is also effective 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 like eczema, seborrheic dermatitis, and psoriasis, as well as for relief from insect bites and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help soothe irritation caused by cosmetics, jewelry, detergents, and soaps.

Additionally, this product offers temporary relief for external anal and genital itching. If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older experiencing discomfort from external anal itching, you can apply the medication to the affected area up to 3 to 4 times a day. Before applying, it's important to clean the area gently with mild soap and warm water, rinsing thoroughly. You can also use a suitable cleansing pad. After cleaning, make sure to dry the area by patting or blotting it with toilet tissue or a soft cloth.

If you are caring for a child under 2 years old, or if the affected child is under 12 years old, it's best to consult a doctor before using this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash or for external genital itching if you have a vaginal discharge—please consult your doctor in these cases. If you experience rectal bleeding, do not use it for external anal itching and seek medical advice immediately.

Additionally, avoid getting the medication in your eyes. For external anal itching, only use the amount directed by your doctor, and never insert it into the rectum using fingers or any devices. Following these guidelines will help ensure your safety while using this product.

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 with external genital itching. Additionally, if you experience rectal bleeding while using it for anal itching, consult a doctor immediately.

If your condition worsens, symptoms persist for more than 7 days, or if they improve and then return within a few days, stop using the product and talk to your doctor. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. If you are 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, lasts more than 7 days, or improves and then returns within a few days, stop using the product and contact your doctor. Avoid starting any other hydrocortisone product without guidance.

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 immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior. If you notice anything concerning, don’t hesitate to reach out for help. Remember, it's always better to be safe and get professional advice in these situations.

Pregnancy Use

You can use Quatriderm (hydrocortisone cream) during pregnancy, as there are no specific warnings, precautions, or dosage changes mentioned for its use. The information provided does not indicate that the product is contraindicated (not recommended) during pregnancy, nor does it highlight any risks to the fetus associated with its use.

However, it's always a good idea to consult with your healthcare provider before using any medication while pregnant, to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Quatriderm 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.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding.

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. 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 about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

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 with local regulations.

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, you should also consult a doctor for guidance.

FAQ

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

It provides 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?

For adults and children 2 years and over, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, ask a doctor.

Are there any contraindications for using this cream?

Do not use it for diaper rash, external genital itching with vaginal discharge, or external anal itching if rectal bleeding occurs. Consult a doctor in these cases.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Can I use Hydrocortisone Cream during pregnancy or while nursing?

There are no specific warnings or contraindications mentioned for use during pregnancy or lactation, but consult your doctor for personalized advice.

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

Stop using the cream and consult your doctor if your condition gets worse, or if symptoms last for more than 7 days or recur within a few days.

What are the storage instructions for Hydrocortisone Cream?

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

Packaging Info

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

Packaging configurations for Quatriderm Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Quatriderm Anti-Itch, 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 relief from inflammation and irritation associated with various skin conditions. The cream is presented in a suitable dosage form for topical application, ensuring ease of use and effective delivery of the active ingredient to the affected area.

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 be undertaken only 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

Use of this product is contraindicated in the following situations:

  • Treatment of diaper rash is not recommended; consult a healthcare professional for appropriate alternatives.

  • The product should not be used for external genital itching in the presence of vaginal discharge; medical advice is required.

  • External anal itching treatment is contraindicated if rectal bleeding occurs; seek medical attention immediately.

  • Avoid contact with the eyes to prevent irritation or injury.

  • For external anal itching, do not exceed the recommended dosage unless directed by a healthcare provider.

  • The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. It is imperative that the product is not allowed to come into 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, it is crucial to avoid inserting the product 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 cases. It should also not be used for external genital itching if there is a vaginal discharge, nor for external anal itching if rectal bleeding is present. 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 for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should be cautioned against 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 using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes. For those experiencing external anal itching, it is advised not to exceed the directed usage 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.

The product is not recommended for the treatment of diaper rash; patients should consult a doctor for such conditions. It should also not be used for external genital itching if there is a vaginal discharge, nor for external anal itching in the presence of rectal bleeding. In these cases, prompt consultation with a healthcare provider is necessary.

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

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Quatriderm Anti-Itch.
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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The use of Quatriderm (hydrocortisone cream) during pregnancy has not been associated with specific warnings, precautions, or dosage modifications. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus associated with its use during pregnancy. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of Quatriderm in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Quatriderm Hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of this product 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 these contexts.

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 speak with their healthcare provider. 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 seek medical advice.

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 advised by a healthcare professional. 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 upon request. 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 potential degradation of the product during storage and transportation.

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 Quatriderm 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 Quatriderm 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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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.