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Dg Health Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 2011
Label revision date
December 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2011
Label revision date
December 10, 2024
Manufacturer
Dolgencorp Inc
Registration number
M017
NDC root
55910-541
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 1% is a maximum strength anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used to treat various conditions, including eczema, insect bites, poison ivy, and dermatitis, as well as to alleviate external anal and genital itching.

This cream works by reducing inflammation and helping to soothe the skin, making it appear healthier by addressing issues like redness, dryness, flaking, and cracking. It is the #1 doctor-recommended choice for managing these types of skin discomforts.

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, insect bites, and reactions to poison ivy, oak, or sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it offers temporary relief for external anal and genital 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 best to consult a doctor before use.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider.

When using this product, never insert it directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the best possible outcome.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash; consult a doctor in these cases. Be careful to keep the product away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional.

If your condition worsens, symptoms last more than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, keep this product out of reach of children, as swallowing it can be harmful; seek medical help or contact a Poison Control Center immediately if this happens.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas, especially if you have a vaginal discharge or diaper rash—consult your doctor in these cases. When applying the product, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using your fingers or any device.

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. If the product is swallowed, get emergency help or contact a Poison Control Center right away 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 be cautious with hydrocortisone cream. The safety of this medication during pregnancy has not been established, so you should consult your doctor before using it. They can provide guidance tailored to your specific situation.

While using hydrocortisone cream, it is essential to follow your doctor's advice and supervision. The potential risks to your fetus (unborn baby) are not clearly defined, so exercising caution is advised. Always prioritize open communication with your healthcare provider regarding any medications you consider during this time.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

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 doctor before using the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance. Always prioritize your child's safety and well-being by seeking professional advice when needed.

Geriatric Use

While there is no specific information about the use of Hydrocortisone Cream 1% in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it's appropriate for your needs and discuss any potential risks or benefits based on your overall health and any other medications you may be taking. Always prioritize safety and seek guidance tailored to your individual situation.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication 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 have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

For treating itching caused by 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. If you are dealing with external anal or genital itching, it's best to first clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication, also up to 3 to 4 times daily.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is a maximum strength anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I use Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, cleanse the area first, then apply the cream.

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

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

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.

Is it safe to use Hydrocortisone Cream during pregnancy?

The safety of Hydrocortisone Cream during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What are the side effects of Hydrocortisone Cream?

Common side effects may include skin irritation. If you experience severe reactions or if the condition worsens, seek medical advice.

How should I store Hydrocortisone Cream?

Store Hydrocortisone Cream at 20-25°C (68-77°F).

What should I do if I accidentally swallow the cream?

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

Packaging Info

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

Packaging configurations for Dg Health Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Cream 1% is a topical formulation designed for the relief of itching and inflammation associated with various skin conditions. This cream contains 1% hydrocortisone as the active ingredient. The product is presented in a net weight of 2 ounces (57 grams).

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, insect bites, poison ivy, poison oak, or poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it provides temporary relief for external anal and genital itching.

Limitations of use: Other applications 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 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 in adults, it is recommended to 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. 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 also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted in such cases.

Avoid contact with the eyes. Do not exceed the recommended dosage unless directed by a healthcare provider. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

When administering 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 physician. Furthermore, the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Patients must be advised 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. It is also crucial to refrain from using any other hydrocortisone products without consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, patients should receive emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if 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 crucial to seek medical advice if rectal bleeding occurs.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Dg Health Hydrocortisone.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

In cases of external anal and genital itching, it is recommended that adults cleanse the affected area with mild soap and warm water, followed by thorough rinsing. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth before application. Similar to the previous indication, pediatric patients under 12 years of age should seek medical advice before use.

Geriatric Use

There is no specific information regarding the use of Hydrocortisone Cream 1% 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 efficacy and potential adverse effects is recommended, given the lack of targeted studies in this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. It is recommended that hydrocortisone cream be used only under the advice and supervision of a doctor during pregnancy. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this medication in pregnant individuals.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

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 communicate that the product is not intended for the treatment of diaper rash, and a consultation with a healthcare professional is recommended for this condition.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor.

In the event of rectal bleeding, patients must stop using the product and seek medical advice. While using the product, patients should be cautioned to 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 provider. 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 temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

For the management of itching associated with skin irritation, inflammation, and rashes, patients aged 2 years and older are advised to apply the treatment to the affected area no more than 3 to 4 times daily. In cases of external anal and genital itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application. This treatment should also be applied to the affected area no more than 3 to 4 times daily.

Drug Information (PDF)

This file contains official product information for Dg Health 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 Dg Health 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.