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Cerave Developed with Dermatologists Anti Itch

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Active ingredient
Hydrocortisone 10 mg/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 2017
Label revision date
December 31, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/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 2017
Label revision date
December 31, 2023
Manufacturer
L'Oreal USA Products Inc.
Registration number
M017
NDC root
49967-108
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema (a chronic skin condition that causes itchy and inflamed skin), seborrheic dermatitis (a skin condition that causes scaly patches and red skin), and psoriasis (a condition that leads to the rapid growth of skin cells, resulting in thick, red, scaly patches). It may also alleviate itching related to soaps, detergents, and cosmetics.

While this product is effective for these common skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

You can use this product to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. This includes conditions like eczema, reactions to soaps, detergents, and cosmetics, as well as seborrheic dermatitis and psoriasis.

For any other uses, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if you have a child under 2 years of age, it’s important not to use this medication without consulting a doctor first. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; if you have concerns about a rash, please consult your doctor. Additionally, do not start using any other hydrocortisone product without first talking to your healthcare provider.

While using this product, be careful to avoid contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and reach out to your doctor for further guidance.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, it's important to stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, you should also seek medical advice before using any other hydrocortisone product.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product and call 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. It's important not to start using any other hydrocortisone product without consulting your doctor first.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or precautions regarding the use of hydrocortisone cream during pregnancy mentioned in the information provided. However, since this product is intended for external use only, you should consult your healthcare provider before using it to ensure it is appropriate for your situation.

While the insert does not list any contraindications or risks to the fetus, it's always best to seek professional advice when considering any medication during pregnancy. Your healthcare provider can help you make informed decisions about your health and the health of 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, exercising caution is 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 under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a loved one is an older adult considering this medication, it’s essential to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. They can help you understand how to manage your health safely and effectively.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

How should I use this product?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Do not use in children under 2 years of age without consulting a doctor.

Are there any contraindications for this product?

Do not use this product for the treatment of diaper rash. Consult a doctor for other uses.

What should I do if my condition worsens?

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

Is this product safe to use during pregnancy?

There are no specific warnings regarding the use of this product during pregnancy, but it is advised to consult a healthcare provider before use.

Can nursing mothers use this product?

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 I accidentally swallow this product?

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

What are the storage conditions for this product?

Store the product at 20° to 25°C (68° to 77°F).

Packaging Info

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

Packaging configurations for Cerave Developed with Dermatologists Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

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 adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a healthcare professional. In such cases, it is advisable to consult a doctor for appropriate guidance.

Contraindications

The use of this product is contraindicated in the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, the initiation of any other hydrocortisone product should only occur after consulting a doctor.

Patients should 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.

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

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, patients are cautioned against initiating the use of any other hydrocortisone product without prior consultation with a healthcare professional. This precaution is essential to ensure safe and effective treatment management.

Side Effects

For external use only. Patients should be 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 the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Cerave Developed with Dermatologists Anti Itch.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; healthcare professionals are advised to consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Hydrocortisone cream is intended for external use only, and while there are no specific warnings or precautions regarding its use during pregnancy, it is advisable for pregnant patients to consult a healthcare provider prior to use. The prescribing information does not indicate any contraindications in pregnancy or known risks to the fetus. However, as with any medication, the use of hydrocortisone cream should be guided by a healthcare professional 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 nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 if the product is swallowed. It is important to inform patients that this product is intended for the treatment of diaper rash and that they should consult a doctor for appropriate guidance.

Patients should be made aware that if their condition worsens, or if symptoms persist for more than 7 days, or if the rash clears up and then recurs within a few days, they should refrain from using any other hydrocortisone product without first consulting a doctor. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes to prevent irritation or injury.

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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Cerave Developed with Dermatologists Anti Itch, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

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.