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Care One Hydrocortisone

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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 2010
Label revision date
September 29, 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 2010
Label revision date
September 29, 2024
Manufacturer
American Sales Company
Registration number
M017
NDC root
41520-319
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 1% Cream is a maximum strength anti-itch cream that contains soothing aloe to help relieve itching quickly. It is designed to temporarily alleviate discomfort associated with minor skin irritations, inflammation, and rashes. This cream can be used for various conditions, including eczema, psoriasis, poison ivy, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps.

By applying Hydrocortisone 1% Cream, you can find relief from external anal and genital itching as well. It is important to note that while this cream is effective for many common skin issues, any other uses should be discussed 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 like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to skin irritations, this product can temporarily relieve itching in the 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 to avoid potential issues. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, do not exceed the recommended dosage unless directed by your healthcare provider, and avoid inserting the product directly into the rectum using fingers or any devices.

While using this product, be careful to keep it away from your eyes to prevent irritation. Always prioritize your health and consult a healthcare professional if you have any questions or concerns.

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; consult a doctor in these cases. Be careful to keep the product 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 requires 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 applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, stop use and seek medical advice. Always keep this product out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately 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 is important to avoid using this product unless your doctor specifically advises you to do so. Your healthcare provider can help you weigh the potential risks and benefits to ensure the safety of both you and your baby. Always consult with your doctor before starting or continuing any medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is experiencing 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 issues related to 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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 should be used if you have hepatic impairment (issues with liver function).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and 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 new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

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

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.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it 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 clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. Remember to follow these guidelines for effective relief.

FAQ

What is Hydrocortisone 1% Cream used for?

Hydrocortisone 1% Cream is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone 1% Cream?

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 contraindications for using this cream?

Do not use Hydrocortisone 1% Cream in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Can I use this cream if I am pregnant or nursing?

Do not use this product if you are pregnant unless directed by a doctor. Nursing mothers should consult a doctor before use, as there is potential for excretion in breast milk.

What are the side effects of Hydrocortisone 1% Cream?

Common side effects may include skin irritation. If you experience severe reactions or symptoms persist, seek medical advice.

How should I store Hydrocortisone 1% Cream?

Store the cream at 20-25°C (68-77°F) to maintain its effectiveness.

Packaging Info

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

Packaging configurations for Care One Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Care One Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone 1% Cream is a topical formulation designed for the relief of itching associated with minor skin irritations. This cream contains hydrocortisone as the active ingredient, providing maximum strength for effective symptom management. The formulation is enhanced with soothing aloe to further alleviate discomfort. Each tube contains a net weight of 1 ounce (28 grams). This product is comparable to the active ingredient found in Cortizone•10® Creme.

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 physician 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 then 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 physician 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; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Care should be taken to avoid contact with the eyes during use.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the genital area if they are experiencing vaginal discharge; consultation with a physician is recommended in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior medical consultation.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. It is crucial that patients adhere strictly to the recommended dosage and not exceed the directed amount unless specifically instructed by a physician.

Patients must be cautioned against inserting the product directly into the rectum using fingers, mechanical devices, or applicators. Should the condition worsen, or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, patients should discontinue use and seek medical advice. Furthermore, if rectal bleeding occurs, immediate consultation with a healthcare professional is necessary.

It is essential to keep this product 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.

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 the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The use of this product or any other hydrocortisone product should not be resumed without medical advice. Immediate medical attention should be sought if rectal bleeding occurs.

To ensure safety, 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 Care One Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Care One Hydrocortisone.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the product is indicated for use in adults and children aged 2 years and older. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

In cases of external anal and genital itching, adults are advised to clean the affected area with mild soap and warm water, rinsing thoroughly. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. Similar to the previous indication, the application frequency is not more than 3 to 4 times daily. For children under 12 years of age, it is recommended to 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients should not use this product unless directed by a healthcare professional. The potential risks associated with the use of this product during pregnancy have not been fully established. Therefore, it is essential for women of childbearing potential to consult with their healthcare provider prior to use to ensure safety for both the mother and the developing fetus.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 product is ingested, healthcare professionals are advised 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 compound in these areas.

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 the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should be instructed 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. They should also be advised not to use this or any other hydrocortisone product unless directed by a doctor. Furthermore, patients should be made aware that they need to stop using the product and seek medical advice if rectal bleeding occurs.

While using this product, patients should be reminded to avoid contact with their eyes. It is essential to emphasize that they should not exceed the recommended dosage unless specifically instructed to do so by a healthcare provider. 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 is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

The medication is administered topically for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application, also not exceeding 3 to 4 times daily.

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 Care One Hydrocortisone, 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 Care One Hydrocortisone, 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.