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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
November 1, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
November 1, 2019
Manufacturer
Safetec of America, Inc.
Registration number
part348
NDC root
61010-4402
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

Safetec® 1% Hydrocortisone Cream is a topical medication designed to provide temporary relief from itching, inflammation, and rashes on the skin. It is commonly used for minor skin irritations caused by conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, as well as seborrheic dermatitis and psoriasis. This cream can also help alleviate external genital, feminine, and anal itching.

The active ingredient, hydrocortisone, works by reducing inflammation and suppressing the immune response in the affected area, which helps to soothe discomfort and promote healing. If you're experiencing any of these skin issues, this cream may be a helpful option for relief.

Uses

You can use this medication for the temporary relief of itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, detergents, cosmetics, and jewelry, as well as conditions like seborrheic dermatitis and psoriasis. Additionally, it is effective for external itching in sensitive areas, including feminine and anal regions.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

If you are using this medication, apply it to the affected area no more than 3 to 4 times a day. For children under 2 years of age, it's important to consult a doctor before use. If the medication is being used for anal itching, start by cleansing the area with mild soap and warm water, then rinse thoroughly. After that, gently dry the area by patting or blotting it with bathroom tissue or a soft cloth before applying the medication.

For children under 12, it's also advisable to consult a doctor before using this medication for anal itching. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely and effectively. You should avoid applying it in your eyes or using it for diaper rash. Additionally, do not use it for external genital or feminine itching if you have a vaginal discharge. Always stick to the recommended daily dosage unless your doctor advises otherwise. Lastly, never insert this product into the rectum using fingers or any mechanical device or applicator.

By following these guidelines, you can help ensure your safety while using this product. If you have any questions or concerns, please consult your healthcare provider.

Side Effects

You should be aware that this product is for external use only and should not be applied to the eyes, used for diaper rash, or applied to external genital areas if you have a vaginal discharge. It's important not to exceed the recommended daily dosage unless directed by a doctor, and you should avoid using it in the rectum with fingers or any devices.

If your condition worsens, symptoms last more than 7 days, or improve and then return within a few days, stop using the product and consult a doctor. Additionally, if you experience any bleeding while using it for anal itching, seek medical advice. Always keep this product out of reach of children, and if swallowed, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

This product is for external use only. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Avoid applying it to your eyes, using it for diaper rash, or for external genital or feminine itching if you have a vaginal discharge. Do not exceed the recommended daily dosage unless directed by your doctor, and do not use it in the rectum with fingers or any device.

If your condition worsens, symptoms last more 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 bleeding while using it for anal itching, seek medical advice. Always keep this product out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor or pharmacist regarding your breastfeeding status when considering treatment options.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before use. Additionally, if your child is under 12 and you are considering it for anal itching, it's best to check with a doctor first to ensure safety and proper use. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When using hydrocortisone cream, there is no specific information provided about its use in older adults. This means that there are no special age-related guidelines, dosage adjustments, or safety concerns specifically for elderly patients. However, as with any medication, it’s always a good idea to consult with a healthcare provider to ensure it’s appropriate for your individual health needs. If you or a loved one are considering using this cream, discussing it with a doctor can help address any potential concerns.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

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

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to 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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any unforeseen issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from excessive heat, as high temperatures can affect its effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Safetec® 1% Hydrocortisone Cream used for?

Safetec® 1% Hydrocortisone Cream is used for the temporary relief of itching, inflammation, and rashes associated with minor skin irritations.

Who can use this cream?

Adults and children 2 years of age and older can use the cream. For children under 2 years, consult a doctor.

How often can I apply the cream?

You can apply the cream to the affected area not more than 3 to 4 times daily.

Are there any contraindications for using this cream?

Yes, do not use the cream in the eyes, for diaper rash, or for external genital itching if you have a vaginal discharge.

What should I do if my condition worsens?

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

Can I use this cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this cream.

What should I do if I accidentally swallow the cream?

Keep the cream out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store Safetec® 1% Hydrocortisone Cream?

Store the cream at room temperature and avoid excessive heat.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Safetec® 1% Hydrocortisone Cream is indicated for the relief of itching, inflammation, and rashes. The product is supplied in a net weight of 1 oz. (28.4 g) and is manufactured by Safetec of America, Inc., located in Buffalo, NY 14215. The reorder number for this product is 53111, and it is made in India.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it is indicated for seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching.

There are no teratogenic or nonteratogenic effects associated with this drug.

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. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of anal itching, it is essential to first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, gently dry the area by patting or blotting with bathroom tissue or a soft cloth before applying the medication.

For children under 12 years of age, consultation with a doctor is recommended before using the product for anal itching.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in or around the eyes.

  • Use for diaper rash.

  • Application for external genital or feminine itching in the presence of vaginal discharge.

  • Exceeding the recommended daily dosage unless directed by a healthcare professional.

  • Insertion of this product into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional prior to use.

The product should not be applied in the eyes, used for diaper rash, or for external genital or feminine itching in the presence of vaginal discharge. It is imperative that patients adhere to the recommended daily dosage and refrain from exceeding it unless directed by a physician. Additionally, this product should not be administered rectally using fingers, mechanical devices, or applicators.

Patients are 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 important to refrain from using any other hydrocortisone products without consulting a healthcare provider. In the event of bleeding associated with anal itching, medical consultation is necessary.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for use in the eyes, for diaper rash, and for external genital or feminine itching in the presence of vaginal discharge. Additionally, patients should not exceed the recommended daily dosage unless directed by a healthcare professional, nor should the product be used rectally with 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 important to seek medical advice if bleeding occurs when the product is used for anal itching.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may 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 doctor prior to use. Additionally, for children under 12 years, consultation with a doctor is recommended before using the medication for anal itching.

Geriatric Use

There is no specific information regarding the use of hydrocortisone cream in geriatric patients provided in the drug insert. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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.

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

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

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 room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.