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Cvs Health Maximum Strength Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
August 2, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
August 2, 2024
Manufacturer
CVS Health
Registration number
M017
NDC root
51316-165
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 is a topical ointment that contains 1% hydrocortisone, a type of corticosteroid. It is designed to temporarily relieve itching and discomfort associated with minor skin irritations, inflammation, and rashes. This includes conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as irritations from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help alleviate external anal and genital itching.

While hydrocortisone is effective for these uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

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, as well as irritations caused by 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 are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it's important to consult a doctor before use.

If you're dealing with external anal itching, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After that, pat or blot the area dry with toilet tissue or a soft cloth before applying the medication. Remember, for children under 12 years of age, you should also check with a doctor before using this treatment.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional.

Side Effects

This product is intended for external use only. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. Additionally, do not start using any other hydrocortisone product without first speaking to your healthcare provider.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that may be ingested. Keep it out of reach of children to prevent accidental swallowing. If you or someone else accidentally swallows the product, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Additionally, do not start using any other hydrocortisone product without first discussing it with your doctor.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional advice if you think something might be wrong.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to using CVS Health Maximum Strength Hydrocortisone ointment while breastfeeding, there is no specific information available about its effects on nursing mothers or lactation (the process of producing breast milk). This means that the drug insert does not provide guidance on how this ointment may affect your milk production or your nursing infant.

If you have concerns about using this ointment while breastfeeding, it’s a good idea to consult with your healthcare provider. They can help you weigh the benefits and any potential risks to ensure the best care for you and your baby.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 years, you should also seek advice from a healthcare professional. For those 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 prioritize your child's safety by following these guidelines.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions outlined for elderly patients, your healthcare provider will be the best resource for determining the appropriate use of this medication based on individual health needs. Always ensure that any treatment plan is tailored to your specific situation.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

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

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone used for?

Hydrocortisone 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?

You should apply Hydrocortisone to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using Hydrocortisone?

Do not use Hydrocortisone 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 Hydrocortisone and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is Hydrocortisone safe to use during pregnancy?

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

What are the storage instructions for Hydrocortisone?

Store Hydrocortisone at a controlled room temperature of 20-25°C (68-77°F).

Can I use Hydrocortisone for external anal itching?

Yes, Hydrocortisone can temporarily relieve external anal itching, but you should clean the area with mild soap and warm water before applying.

What should I do if I accidentally swallow Hydrocortisone?

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

Packaging Info

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

Packaging configurations for Cvs Health Maximum Strength Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Cortisone Ointment contains hydrocortisone at a concentration of 1%. The formulation is provided in a net weight of 1.0 oz (28 g). This topical preparation is designed for the management of inflammatory skin 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, 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

Adults and children aged 2 years and older are instructed to apply the medication to the affected area no more than 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 itching, adults should, when practical, cleanse the affected area using mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application of the medication.

For children under 12 years of age, it is advised to seek guidance from a healthcare professional before administering the medication.

Contraindications

Use 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.

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

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician 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 against initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. It is also recommended that patients do not begin use of any other hydrocortisone product unless they have consulted a doctor.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Cvs Health Maximum Strength Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is also recommended to seek medical advice prior to application.

For adults and pediatric patients aged 2 years and older, the product 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding the use of CVS Health Maximum Strength Hydrocortisone ointment in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers. The effects on breastfed infants have not been established, and further data may be necessary to inform clinical decisions.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 context of overdosage, it is important to note that there is no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed overdosage data, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to contact a poison control center or seek expert consultation for guidance on management strategies. Continuous assessment and appropriate interventions are essential to ensure patient safety and mitigate any potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients 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. Patients should also be cautioned against using any other hydrocortisone product without first consulting a doctor.

While using this product, patients should avoid contact with their eyes. It is essential to inform patients not to exceed the directed dosage unless specifically instructed to do so by a healthcare professional. Furthermore, patients 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 is essential to store the product at a controlled room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cvs Health Maximum Strength 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 Cvs Health Maximum Strength 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.