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Careall Hydrocortisone

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Active ingredient
Hydrocortisone 0.01 g/1 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 2024
Label revision date
December 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/1 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 2024
Label revision date
December 1, 2025
Manufacturer
New World Imports, Inc
Registration number
M017
NDC root
51824-097
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 is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, and sumac, as well as insect bites and irritations from detergents, jewelry, and soap. Additionally, it may be used for external genital, perianal, and anal itching.

While hydrocortisone cream is effective for these purposes, it's important to use it under the guidance of a healthcare professional for any other uses. This ensures that you receive the best care tailored to your specific needs.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations and conditions. This includes relief from itching associated with eczema, psoriasis, and rashes due to poison ivy, oak, and sumac. It can also help with itching from insect bites, reactions to detergents or jewelry, seborrheic dermatitis, and soap. Additionally, it may provide relief for external genital, geminine, and anal itching.

For any other uses, it's important to consult with your doctor for advice 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 around the anal and genital areas, adults and children aged 12 years and older should first clean the area gently with mild soap and warm water, then rinse thoroughly. After drying the area by patting it with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If your child is under 12 years old and experiencing external anal itching, please consult a doctor for guidance.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care if the medication is swallowed. In such a case, seek medical help immediately or contact a Poison Control Center for assistance. Your safety is paramount, so please follow these guidelines closely.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. If you experience any worsening of your condition, persistent symptoms for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and consult your doctor. Additionally, do not use it for diaper rash or if you have vaginal discharge without first speaking to a healthcare professional.

If you notice rectal bleeding, seek medical advice immediately. Remember to follow the usage instructions carefully and do not exceed the recommended amount unless directed by your doctor.

Warnings and Precautions

This product is for external use only and should not be used to treat diaper rash. If you notice any vaginal discharge, please consult your doctor. While using this product, avoid getting it in your eyes, and do not exceed the recommended dosage unless directed by your doctor. It's important not to insert this product into the rectum using fingers or any device. If you experience rectal bleeding, seek medical attention immediately.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that this product is contraindicated (not recommended) for pregnant individuals, nor are there any noted risks to the fetus associated with its use.

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

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 under 2 years old, it's important not to use this medication without consulting a doctor first. For children experiencing external anal and genital itching, you should also consult a doctor if they are under 12 years of age.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow your healthcare provider's advice to ensure your child's safety and well-being.

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. If you are treating external anal and genital itching, this same frequency applies, but it is recommended for adults and children aged 12 years and older. Always follow the instructions provided by your healthcare provider for the best results.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes, do not use for diaper rash, and consult a doctor if rectal bleeding occurs.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Can I use Hydrocortisone Cream during pregnancy?

The insert does not provide specific information regarding the use of Hydrocortisone Cream during pregnancy, so consult your doctor for advice.

Is it safe to use Hydrocortisone Cream while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

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

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

How should I store Hydrocortisone Cream?

Store at room temperature and keep out of reach of children. Discard the product after opening.

Packaging Info

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

Packaging configurations for Careall Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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, and sumac, insect bites, reactions to detergents and jewelry, seborrheic dermatitis, and soap. It is also indicated for external genital, perineal, and anal itching.

Limitations of Use Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

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. It is contraindicated for use in children under 2 years of age; consultation with a physician is advised in such cases.

In the case of external anal and genital itching, adults and children aged 12 years and older should first cleanse 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 experiencing external anal itching, it is recommended to consult a physician before use.

Contraindications

There are no contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

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 management in such cases. Patients experiencing vaginal discharge should also seek medical advice prior to use.

When utilizing 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 healthcare provider. Additionally, this product should not be administered rectally using fingers, mechanical devices, or applicators. In the event of rectal bleeding, patients must consult a doctor without delay.

Healthcare professionals should advise 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 refrain from using any other hydrocortisone products unless they have consulted a doctor.

In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for the treatment of diaper rash and in cases of vaginal discharge; consultation with a doctor is advised in these situations.

While using this product, patients must avoid contact with the eyes and should not exceed the recommended dosage unless directed by a healthcare professional. Additionally, it is important to refrain from inserting the product into the rectum using fingers or any mechanical device or applicator. Should rectal bleeding occur, patients are advised to consult a doctor promptly.

Patients should discontinue use and seek medical advice 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 recommended that patients do not initiate the use of any other hydrocortisone product without first consulting a doctor.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Careall Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For external anal and genital itching, it is advised that children under 12 years of age consult a doctor prior to use. For those aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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.

Pregnancy

The use of hydrocortisone cream during pregnancy does not have specific warnings or precautions outlined in the available prescribing information. There is no indication that the product is contraindicated for use in pregnant patients, nor are there any documented risks to the fetus associated with its application during pregnancy. Healthcare professionals should consider the benefits and potential risks when recommending this treatment to women of childbearing potential.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies as needed.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to prevent any potential risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily to the affected area. For external anal and genital itching, the same frequency applies specifically to adults and children aged 12 years and older.

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 Careall 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 Careall 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.

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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.