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Caring Mills Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2023
Label revision date
December 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2023
Label revision date
December 18, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-800
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

Caring Mills 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, or sumac. Additionally, it may alleviate itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis, as well as external anal and genital itching.

This cream works by reducing inflammation and soothing the affected area, making it easier for you to manage discomfort. However, it's important to use this product under the advice and supervision of a doctor for any other uses beyond its general applications.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It’s also effective for soothing itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can help 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 physician before use.

For external itching in the anal and genital areas, adults and children aged 12 and older should first clean the area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting or blotting 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, please consult a physician for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it to the genital area if you have a vaginal discharge, as this could lead to complications. Additionally, avoid using it for treating diaper rash, as it is not intended for that purpose. If you are considering using this medication alongside any other hydrocortisone products, please consult your doctor first to ensure it's safe for you.

Side Effects

When using this product, it's important to follow the directions carefully. You should avoid using it in the genital area if you have a vaginal discharge, for diaper rash, or with any other hydrocortisone product unless advised by a doctor. Be cautious to keep it away from your eyes and do not exceed the recommended dosage without consulting a healthcare professional.

If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and contact your doctor. Additionally, if the product is swallowed, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid using it on the genital area if you have a vaginal discharge or for treating diaper rash. It's important to use this medication exactly as directed and not to combine it with other hydrocortisone products unless your doctor has advised you to do so. Be careful to keep it away from your eyes and do not apply it directly into the rectum using fingers or any devices.

If your condition worsens, if 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, you should also stop use and seek medical advice. Always keep this product out of reach of children, and if it is 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's important to know that there is no specific information available about the use of Caring Mills Hydrocortisone Cream during pregnancy. This means that safety concerns, dosage adjustments, or special precautions related to its use in pregnant individuals have not been clearly established.

Before using this cream, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider during pregnancy.

Lactation Use

If you are breastfeeding, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is strongly advised. 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 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 physician (doctor) before using the product.

For external anal and genital itching, the treatment is suitable for adults and children aged 12 years and older. In this case, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the treatment up to 3 to 4 times daily. If your child is younger than 12, please consult a physician for guidance.

Geriatric Use

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

Renal Impairment

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 monitor your kidney function 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 if you have hepatic impairment (liver issues).

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 be cautious when using hydrocortisone. You should not use it alongside any other hydrocortisone products unless you have consulted with your doctor. This is crucial because combining these medications can lead to unwanted side effects or complications.

Always discuss any medications you are taking with your healthcare provider to ensure they are safe to use together. Your health and safety should always come first, so don't hesitate to ask questions or seek guidance.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety. It's also important to check the tube seal under the cap before use; if the seal is broken, do not use the product, as this could compromise its integrity.

Always handle the product with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, meaning it is meant to be applied directly to the skin. If your condition worsens, if 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. It's important not to start using any other hydrocortisone product without first discussing it with your doctor.

FAQ

What is Caring Mills Hydrocortisone Cream used for?

Caring Mills Hydrocortisone Cream temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I use Caring Mills Hydrocortisone Cream?

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 physician.

Are there any precautions I should take when using this cream?

Use only as directed, avoid contact with eyes, and do not use more than directed unless advised by a doctor. Do not use in the genital area if you have a vaginal discharge.

What should I do if my condition worsens?

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

Can I use this cream while pregnant or breastfeeding?

There is no specific information regarding use during pregnancy. Nursing mothers should consult a physician before use, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow the cream?

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

How should I store Caring Mills Hydrocortisone Cream?

Store the cream at 20-25°C (68-77°F) and do not use it if the tube seal under the cap is broken.

Packaging Info

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

Packaging configurations for Caring Mills Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Caring Mills Hydrocortisone Cream is a topical formulation containing hydrocortisone as the active ingredient. This cream is presented in a 2-ounce tube, designed for local application to the skin. The formulation is intended for the relief of inflammation and itching associated with various dermatological conditions.

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 exposure, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. 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 following dosing guidelines are recommended:

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching, adults and children aged 12 years and older should first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleaning, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. 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 physician is recommended before application.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in patients with a vaginal discharge due to the potential for exacerbating the condition. It is also contraindicated for the treatment of diaper rash, as this may lead to adverse effects. Additionally, concurrent use with any other hydrocortisone product is not recommended unless directed by a healthcare professional, to avoid the risk of excessive corticosteroid exposure.

Warnings and Precautions

For external use only, this product is contraindicated for application in the genital area, particularly in the presence of vaginal discharge. It is also not indicated for the treatment of diaper rash. Healthcare professionals should advise patients against using this product in conjunction with any other hydrocortisone formulations unless specifically directed by a physician.

Patients must adhere strictly to the recommended usage guidelines. Contact with the eyes should be avoided to prevent irritation. The product should not be applied in excess of the prescribed amount unless otherwise instructed by a healthcare provider. Additionally, it is imperative that the product is not administered directly into the rectum using fingers, mechanical devices, or applicators.

Patients should be instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist beyond 7 days, or if there is a recurrence of symptoms after initial improvement. The use of any other hydrocortisone product should not commence without prior consultation with a healthcare professional. 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, it is crucial to 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, for the treatment of diaper rash, or in conjunction with any other hydrocortisone product unless directed by a healthcare professional.

While using this product, patients are advised to follow the instructions carefully, avoiding contact with the eyes and not exceeding the recommended dosage unless specifically instructed by a doctor. It is important to refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should 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. Additionally, if rectal bleeding occurs, medical advice should be sought immediately.

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

Co-administration of this product with other hydrocortisone formulations is contraindicated unless specifically directed by a healthcare professional. The use of multiple hydrocortisone products may increase the risk of systemic side effects and potential overdose. It is essential for healthcare providers to evaluate the necessity of concurrent therapy and to monitor for any adverse effects if such combinations are deemed necessary.

Packaging & NDC

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

Packaging configurations for Caring Mills Hydrocortisone.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

In cases of external anal and genital itching, the medication is indicated for adults and children aged 12 years and older, who should first clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry the area before application. This group may also apply the medication up to 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician 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.

Pregnancy

There is no specific information available regarding the use of Caring Mills Hydrocortisone Cream during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for women of childbearing potential. It is advisable to discuss any concerns with patients and consider alternative treatments if necessary.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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 to ensure safety and efficacy.

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. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate actions to take.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be instructed to use the medication only as directed and to avoid contact with the eyes. It is important to emphasize that patients should not exceed the recommended dosage unless specifically directed to do so by a healthcare professional. Additionally, patients should be cautioned against inserting the medication directly into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format. It should be stored at a temperature range of 20-25°C (68-77°F). It is imperative that the product is not used if the tube seal under the cap is broken, as this may compromise the integrity of the product.

Additional Clinical Information

The route of administration for the product is topical. Clinicians should counsel patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be advised to seek medical attention if rectal bleeding occurs and to refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

Drug Information (PDF)

This file contains official product information for Caring Mills 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 Caring Mills 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.