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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)
Marketed in the U.S.
Since 2018
Label revision date
October 30, 2024
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
Marketed in the U.S.
Since 2018
Label revision date
October 30, 2024
Manufacturer
Meijer Distribution Inc
Registration number
M013
NDC root
41250-369

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Drug Overview

Hydrocortisone 1% is a maximum strength anti-itch cream designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, psoriasis, and reactions to poison ivy, insect bites, and various skin irritants like detergents and cosmetics. This cream features an Intensive Healing Formula enriched with chamomile and antioxidants, along with vitamins A, C, and E, which help to moisturize the skin for up to 24 hours.

As the #1 doctor-recommended active ingredient for relieving itch, hydrocortisone works by reducing inflammation and soothing the skin. It can also be used to alleviate external anal and genital itching. For any other uses, it is advisable to consult with a doctor.

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, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product 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'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 external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or in the genital area if you have a vaginal discharge—please consult your doctor in these cases. While using this product, make sure to avoid contact with your eyes, and do not exceed the recommended dosage unless your doctor advises otherwise. Additionally, do not insert the product directly into the rectum using your fingers or any device.

Remember, following these guidelines helps prevent misuse and ensures your safety while using the product. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If your condition worsens, persists for more than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, do not use this product for diaper rash or in the genital area if you have a vaginal discharge without first asking a doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is intended for external use only. It should not be used to treat diaper rash, and if you have a vaginal discharge, consult your doctor before using it in the genital area.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

In case of accidental swallowing, it’s important to get emergency medical help right away or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone cream during pregnancy. The information available does not indicate any contraindications (situations where the product should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication, including hydrocortisone cream, to ensure it is safe for your specific situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions related to lactation (the process of producing milk) or concerns about the product being passed into breast milk. This means you can use the product without worrying about potential effects on your milk production or your nursing infant.

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 external anal and genital itching, it's recommended that you speak with a doctor if your child is under 12 years old. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. 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 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 feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

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

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use and disposal to ensure safety and compliance. Proper storage and handling are key to achieving the best results.

Additional Information

You should apply this medication topically to the affected area, no more than 3 to 4 times a day. If you're treating external anal and genital itching, it's best to first clean the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting with toilet tissue or a soft cloth before applying the medication.

If you are using this medication for a child under 2 years old, do not use it without consulting a doctor. For children under 12 years, it's also advisable to ask a doctor before use.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I use Hydrocortisone 1%?

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

Are there any warnings for using Hydrocortisone 1%?

Yes, avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. If symptoms worsen or persist for more than 7 days, consult a doctor.

Can I use Hydrocortisone 1% for diaper rash?

No, do not use Hydrocortisone 1% for the treatment of diaper rash. Consult a doctor for appropriate treatment.

Is Hydrocortisone 1% safe to use during pregnancy?

The provided information does not mention specific safety concerns or recommendations for using Hydrocortisone 1% during pregnancy.

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

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

What are the key ingredients in Hydrocortisone 1%?

Hydrocortisone 1% contains an intensive healing formula with chamomile, antioxidants, and vitamins A, C, and E.

How should I store Hydrocortisone 1%?

Store Hydrocortisone 1% at a temperature between 20°-25°C (68°-77°F).

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 1% is a topical formulation designed for intensive healing, incorporating vitamins A, C, and E, along with chamomile and antioxidants. This product is presented in a net weight of 2 ounces (56 grams). The formulation aims to provide therapeutic benefits through its active and inactive ingredients, promoting skin health and recovery.

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, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it 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 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; healthcare professionals should be consulted.

In cases of external anal and genital itching in adults, it is advisable to first clean 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, consultation with a healthcare professional is recommended before use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a healthcare professional should be consulted.

Contact with the eyes must be avoided during use. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate alternatives. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a consultation with a healthcare provider is recommended.

Patients should be instructed 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. It is important to note that patients should not initiate the use of any other hydrocortisone product without first consulting a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

In cases of accidental ingestion, patients should seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

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

Patients are advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, medical advice should be sought immediately.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anti Itch.
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 genital itching, it is recommended that children under 12 years of age consult a doctor 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. 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

There are no specific statements regarding the use of hydrocortisone cream during pregnancy in the provided information. The insert does not mention any safety concerns, contraindications, or special precautions regarding the use of this product during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of hydrocortisone cream.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 at 1-800-222-1222 if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives.

Patients should be cautioned against using the product in the genital area if they have a vaginal discharge, and they should be encouraged to seek medical advice in such cases. Providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be advised not to start using any other hydrocortisone product without first consulting a healthcare professional.

Patients must be informed to stop using the product and seek medical attention if they experience rectal bleeding. It is also essential to remind patients to avoid contact with the eyes while using this product. Providers should emphasize the importance of adhering to the recommended dosage and instruct patients not to exceed the directed amount unless specifically advised by a doctor. Lastly, patients should be cautioned against inserting the product directly 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 should be stored at a controlled room temperature of 20°-25°C (68°-77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For external anal and genital itching in adults, it is advised to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. The use of this medication is not recommended for children under 2 years of age, and those under 12 years should consult a doctor prior to use.

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, 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.

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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.