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Berkley and Jensen 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 2014
Label revision date
October 19, 2024
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 2014
Label revision date
October 19, 2024
Manufacturer
BJWC
Registration number
M017
NDC root
68391-100
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

1% Hydrocortisone is an anti-itch cream designed to relieve itching caused by minor skin irritations, inflammation, and rashes. It is commonly recommended for conditions such as eczema, psoriasis, poison ivy, oak, sumac, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. This cream also provides temporary relief for external anal and genital itching and contains calming Aloe Vera to soothe the skin.

As the #1 doctor-recommended anti-itch active ingredient, 1% Hydrocortisone can help you find comfort from bothersome itching and irritation. 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, 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 relieve external itching in the 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. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's important to consult a doctor before use.

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 in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. While using this product, make sure to avoid contact with your eyes. Additionally, do not exceed the recommended dosage unless your doctor advises you to do so. Lastly, refrain from inserting the product directly into the rectum using your fingers or any devices. Following these guidelines will help ensure your safety and the best possible outcome.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor. Be careful to keep it away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional.

If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, keep this product out of reach of children, as swallowing it can require immediate medical attention or a call to Poison Control at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas, especially if you have a vaginal discharge or diaper rash—consult your doctor in these cases. When applying the product, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using your fingers or any device.

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 consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. If the product is swallowed, get emergency help or contact a Poison Control Center right away 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 on 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 be cautious with certain products. Specifically, you should avoid using this product in the genital area if you have a vaginal discharge, as this could indicate an underlying issue that requires medical attention. Additionally, do not use this product for treating diaper rash; instead, consult your doctor for appropriate treatment options.

Always prioritize your health and the health of your baby by discussing any concerns or questions with your healthcare provider. They can provide guidance tailored to 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 known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

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 the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance before use.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 kidney health. They can help monitor your condition 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 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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

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

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

Additional Information

You can apply this medication to the affected area of your skin up to 3 to 4 times a day. If you're treating external anal or 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 old, it's also advisable to ask a doctor before use.

FAQ

What is 1% Hydrocortisone used for?

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

How should I use 1% Hydrocortisone?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, clean the area first, then apply the cream.

Are there any warnings for using 1% Hydrocortisone?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

What should I do if my condition worsens while using this product?

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

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

There are no specific warnings regarding the use of this product during pregnancy or lactation, but consult your doctor for personalized advice.

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

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

Can children use 1% Hydrocortisone?

Children under 2 years of age should not use this product without consulting a doctor, and children under 12 years should also ask a doctor before use.

Packaging Info

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

Packaging configurations for Berkley and Jensen Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains 1% hydrocortisone, serving as the active ingredient for its anti-itch properties. It is complemented by calming aloe vera, enhancing its soothing effects. The product is presented in a maximum strength anti-itch cream dosage form, packaged in two 2-ounce tubes, providing a total net weight of 4 ounces (112 grams). This value pack is designed for effective relief from itching.

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; consultation with a healthcare professional is advised.

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 be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted in such cases.

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

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

Patients must be advised 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 also crucial to refrain from using this or any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, patients should receive 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 intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using 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 doctor. Furthermore, 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 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. It is also crucial to seek medical attention if rectal bleeding occurs.

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

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Berkley and Jensen Anti Itch.
Details

Pediatric Use

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

For external anal and genital itching, the medication is intended for adult use. It is recommended that the affected area be cleaned with mild soap and warm water, rinsed thoroughly, and gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. Similar to the previous indication, children under 12 years of age should consult a doctor before use.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised against using this product in the genital area if they have a vaginal discharge, as this may indicate an underlying condition that requires medical evaluation. Additionally, this product is not indicated for the treatment of diaper rash; therefore, pregnant patients should consult a healthcare professional for appropriate management options in such cases. The safety and efficacy of this product during pregnancy have not been established, and caution is recommended.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

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 specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients must be instructed to stop using the product 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. They should also be cautioned against using this or any other hydrocortisone product unless directed by a doctor.

If rectal bleeding occurs, patients should discontinue use and seek medical advice. While using this product, patients should avoid contact with their eyes to prevent irritation.

It is important to remind patients not to exceed the recommended dosage unless specifically instructed by a healthcare provider. Furthermore, they should be advised 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) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling considerations should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For adults experiencing external anal and genital itching, it is recommended to first clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth 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 experience.

Drug Information (PDF)

This file contains official product information for Berkley and Jensen 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 Berkley and Jensen 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.