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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 2013
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 2013
Label revision date
December 12, 2023
Manufacturer
Weeks & Leo Co. , Inc.
Registration number
M017
NDC root
11383-292
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% is a topical medication designed to help relieve severe itching caused by various skin conditions, including eczema, psoriasis, and reactions to insect bites or plants like poison ivy, poison oak, and poison sumac. It works by providing temporary relief from itching associated with minor skin irritations, inflammation, and rashes.

In addition to these uses, Hydrocortisone Cream can also alleviate itching related to cosmetics, jewelry, detergents, and soaps. For external anal and genital itching, this cream may also be effective. However, it's important to use this product under the advice and supervision of a doctor for any other applications.

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. However, for any other uses, it’s important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you or your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if your child is under 2 years old, it’s important to consult a doctor before using the medication. This will help ensure safety and effectiveness for younger children.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; instead, consult your doctor for appropriate options. Additionally, avoid starting any other hydrocortisone products while using this medication, as this could lead to complications. Be careful not to get the medication in your eyes, as this can cause irritation or damage. Always follow these guidelines to ensure your safety and the effectiveness of your treatment.

Side Effects

When using this product, it's important to remember that it is for external use only and should not come into contact with your eyes. If you notice that your condition worsens, or if symptoms persist for more than 7 days or improve and then return shortly after, stop using the product and consult your doctor. Additionally, this product should not be used for treating diaper rash; please ask a doctor for guidance in such cases.

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

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. It is not intended for treating diaper rash; if you have questions about that, consult your doctor.

If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and reach out to your doctor. It's important not to start using any other hydrocortisone product without guidance.

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

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain treatments. For instance, you should not use this product for diaper rash without consulting your doctor first. If your condition worsens, or if symptoms persist for more than seven days, or improve and then return shortly after, stop using the product and seek medical advice.

Additionally, if you have a child under the age of 2, it's essential to talk to a doctor before using this product. Always prioritize your health and the health of your baby by seeking professional guidance when it comes to medication and treatments during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about using medications 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 the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

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 daily if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% helps relieve severe itching from conditions like eczema, psoriasis, insect bites, and reactions to poison ivy, poison oak, and sumac.

How should I use Hydrocortisone Cream 1%?

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?

There are no specific contraindications mentioned, but do not use it for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition gets worse, or if symptoms last for more than 7 days or recur within a few days.

Is it safe to use Hydrocortisone Cream 1% during pregnancy or while nursing?

There are no teratogenic effects mentioned, and no specific warnings for nursing mothers, but consult your doctor for personalized advice.

What precautions should I take when using this cream?

For external use only; avoid contact with eyes, and keep out of reach of children. If swallowed, seek medical help immediately.

Can I use other hydrocortisone products while using this cream?

Do not begin use of any other hydrocortisone product without consulting a doctor.

Packaging Info

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

Packaging configurations for Anti Itch.
Details

Drug Information (PDF)

This file contains official product information for 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% is a topical formulation that combines hydrocortisone, an anti-inflammatory corticosteroid, with the soothing properties of oats, aloe, and vitamin E. This cream is designed for the relief of skin irritation and inflammation. The active ingredient, hydrocortisone, is present at a concentration of 1%, providing effective anti-inflammatory action. The inclusion of oats and aloe enhances the cream's emollient properties, while vitamin E contributes to skin nourishment and protection. The cream is intended for external use and is formulated to be applied directly to affected areas of 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

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician before use. This precaution is necessary to ensure safety and appropriateness of treatment for this age group.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, the initiation of any other hydrocortisone product concurrently is not recommended. Care should be taken to avoid contact with the eyes, as this may lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes during application. This product is not indicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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.

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

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. The product is not indicated for the treatment of diaper rash; patients should consult a doctor for appropriate alternatives.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and seek medical advice. Additionally, patients should refrain from initiating the use of any other hydrocortisone products without consulting a healthcare professional.

This product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 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.

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

Pregnant patients should be advised that this product is not indicated for the treatment of diaper rash. It is important for healthcare providers to counsel women of childbearing potential to seek medical advice if they have any questions regarding its use during pregnancy.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients should discontinue use and consult a healthcare professional. Additionally, this product is not recommended for use in children under 2 years of age without prior consultation with a doctor.

Healthcare providers should consider these factors when advising pregnant patients or those planning to become pregnant.

Lactation

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

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Patients should be informed that this product is intended for the treatment of diaper rash and that they should consult a doctor for further guidance.

It is important to instruct patients to monitor their condition closely. If the diaper rash worsens, or if symptoms persist for more than 7 days, or if the rash clears up and then recurs within a few days, they should discontinue use and consult a healthcare professional. Patients should also be cautioned against using any other hydrocortisone products concurrently without prior consultation.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes, as this product should not be applied in that area.

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 potential degradation of the product during storage and transportation.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.

Learn more in our Editorial Policy

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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.