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Dg Health Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
November 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
November 15, 2024
Manufacturer
Dolgencorp, LLC
Registration number
M017
NDC root
55910-504
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 effective for various conditions, including eczema, psoriasis, insect bites, and reactions to plants like poison ivy, oak, and sumac. This cream can also help alleviate itching from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis, as well as external anal and genital itching.

Enriched with aloe and vitamins A and E, Hydrocortisone Cream works quickly to relieve itchiness and can last for up to 10 hours when used as directed. It is important to use this product under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema and psoriasis, as well as reactions to poison ivy, oak, and sumac. It can also help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can temporarily relieve itching in the external anal and genital areas. If you have other concerns or conditions, it's best to consult with your doctor for guidance on how to use this product safely.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For external itching in 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 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge; it's important to consult a doctor in such cases. Additionally, do not use it for treating diaper rash without medical advice. Always keep the product away from your eyes, and follow the usage instructions carefully—do not exceed the recommended amount unless directed by a healthcare professional. Lastly, avoid inserting the product directly into the rectum using fingers or any devices. If you have any questions or concerns, please reach out to your doctor for guidance.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor.

Additionally, this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on internal areas, especially if you have a vaginal discharge or are treating diaper rash—consult your doctor in these cases.

If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Keep this product out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority.

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.

Additionally, if your doctor does recommend using hydrocortisone cream, it should only be done under their supervision. While the exact risks to the fetus are not clearly defined, it's best to approach this medication with care. Always prioritize open communication with your healthcare provider regarding any treatments during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant while you are lactating (producing milk).

Always consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding, but current guidelines suggest that hydrocortisone cream is generally considered safe for nursing mothers.

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 before use.

Geriatric Use

When using Hydrocortisone Cream 1%, it's important to note that there is no specific information available regarding its use in older adults. This means that there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional before starting any new medication, including topical treatments like this cream. They can provide personalized advice based on individual health needs and conditions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

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 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 an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, psoriasis, and insect bites.

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, clean the area first, then apply the cream as directed.

Are there any contraindications for using this cream?

Do not use Hydrocortisone Cream 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 the cream and ask a doctor if your condition worsens, if 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, so consult a doctor before use.

What should I avoid while using this cream?

Avoid contact with the eyes, do not use more than directed unless told by a doctor, and do not apply directly into the rectum.

How should I store Hydrocortisone Cream?

Store the cream at 20°-25°C (68°-77°F).

What should I do if I swallow the cream?

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

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 associated with minor skin irritations. This cream is enriched with ten moisturizers, including aloe, and is supplemented with vitamins A and E to enhance skin hydration and nourishment. The product is presented in a net weight of 2 ounces (56 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, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it is indicated for the temporary relief of 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 recommended dosage for adults and children 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, the use of this product is not recommended; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

Use 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 for appropriate alternatives.

Contact with the eyes must be avoided to prevent irritation or injury. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, direct application into the rectum using fingers or any mechanical device or applicator is contraindicated.

Warnings and Precautions

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

Patients should be instructed 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 important to note that patients should not initiate the use of any other hydrocortisone product without first consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, it is imperative to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and for the treatment of diaper rash; in such cases, consultation with a doctor is advised.

During the use of this product, patients should avoid contact with the eyes and adhere strictly to the directed dosage. It is important not to exceed the recommended use unless specifically instructed by a healthcare professional. Additionally, 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 the 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.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and genital itching, the medication is intended for adult use. For pediatric patients under 12 years of age, it is recommended to consult a doctor prior to use. When applicable, the affected area should be cleaned with mild soap and warm water, rinsed thoroughly, and gently dried by patting or blotting with toilet tissue or a soft cloth before applying the medication. The same application frequency of not more than 3 to 4 times daily applies.

Geriatric Use

Elderly patients may not have specific information regarding the use of Hydrocortisone Cream 1%, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or changes in response to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of Hydrocortisone Cream 1% for geriatric patients.

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 warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. Instruct patients that if the product is swallowed, they 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, they should be cautioned against using the product for the treatment of diaper rash without first consulting a healthcare professional.

It is important for patients to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to discontinue use and consult a doctor if symptoms clear up and then recur within a few days. Patients should not begin the use of any other hydrocortisone product without first discussing it with their healthcare provider.

Patients should be made aware that rectal bleeding is a serious side effect, and they should stop using the product and contact a doctor if this occurs. While using the product, patients should avoid contact with the eyes and should not exceed the directed dosage unless instructed by a healthcare professional. Furthermore, patients should be cautioned 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 should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, patients aged 2 years and older should apply the medication 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 clean 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 before application. This should also be done 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.