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Crane Safety Hydrocortisone

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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 2020
Label revision date
March 16, 2026
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 2020
Label revision date
March 16, 2026
Manufacturer
Crane Safety LLC
Registration number
M017
NDC roots
73408-633, 73408-933
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

Hydrocortisone Cream 1% is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be used for various types of itching, including external genital, feminine, and anal itching. This cream works by reducing inflammation and soothing the affected area, helping you feel more comfortable.

While it is effective for these purposes, it's important to use Hydrocortisone Cream 1% as directed and consult a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is also effective for alleviating itching in external genital areas, as well as feminine and anal itching.

If you have other uses in mind for this product, it's important to consult with your doctor first to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For best results, especially for external genital itching, it’s a good idea to first clean the area with mild soap and warm water, then rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if your child is under 12 years of age, it’s important to ask a doctor before use to ensure safety and proper care.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash or in combination with any other hydrocortisone product unless you've spoken with your doctor first. Additionally, if you have vaginal discharge, please consult your doctor before using this medication.

Always prioritize your health by following these guidelines to avoid potential complications. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to use this product only on the skin and not for any other purposes. If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then come back within a few days, you should stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Warnings and Precautions

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

You should stop using this product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, it’s important to stop use and consult your doctor right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information available about the use of Crane Safety Hydrocortisone Cream during pregnancy is limited. The drug insert does not provide specific guidance on safety, dosage adjustments, or any special precautions for pregnant individuals.

Given this lack of information, it's advisable to consult with your healthcare provider before using this cream. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize your health and the health of your baby when considering any medication during pregnancy.

Lactation Use

Currently, there is no specific information available about the use of Crane Safety Hydrocortisone Cream for nursing mothers or its effects during breastfeeding. This means that if you are breastfeeding, you should consult your healthcare provider for personalized advice regarding the use of this cream. They can help you understand any potential risks and ensure the safety of both you and your baby.

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 between 2 and 12 years of age, you should also check with a doctor before use.

For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this 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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always prioritize open communication with your healthcare team, especially regarding any changes in health or concerns about side effects. Your safety and well-being are paramount, so don’t hesitate to ask questions or seek guidance tailored to your unique situation.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment is safe and effective. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 59º to 86ºF (15º to 30ºC). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, check the packaging carefully. Do not use it if the packet is torn, cut, or opened, as this indicates that it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is used for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes, including external genital, feminine, and anal itching.

How should I apply Hydrocortisone Cream?

For adults and children 2 years of age and over, apply to the affected area not more than 3 to 4 times daily. For external genital itching, clean the area with mild soap and warm water before applying.

Are there any age restrictions for using this cream?

Do not use Hydrocortisone Cream for children under 2 years of age without consulting a doctor. For children under 12 years, you should also ask a doctor.

What should I avoid while using this cream?

Do not use Hydrocortisone Cream for the treatment of diaper rash, with any other hydrocortisone product unless advised by a doctor, or if you have vaginal discharge.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

How should I store Hydrocortisone Cream?

Store the cream at room temperature between 59º to 86ºF (15º to 30ºC) and avoid excessive heat and humidity.

Is there any information about using this cream during pregnancy?

There is no specific information regarding the use of Hydrocortisone Cream during pregnancy in the provided drug insert.

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 Crane Safety Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crane Safety Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes. It is also indicated for the relief of external genital, feminine, and anal itching.

Limitations of Use: Other uses for 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 medication should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the medication.

For children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted. Additionally, for children under 12 years of age, it is advised to seek guidance from a doctor before use.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash. Additionally, concurrent use with any other hydrocortisone product is contraindicated unless a healthcare professional has been consulted. The product should not be used in patients presenting with vaginal discharge; medical consultation is advised in such cases.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Additionally, patients should be instructed to stop use and seek medical advice if rectal bleeding occurs.

No specific laboratory tests are recommended for monitoring the use of this product. However, vigilance in monitoring patient responses and adverse effects is essential to ensure safe and effective use.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Additionally, patients should seek medical advice if rectal bleeding occurs.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Crane Safety Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and are advised to consult a doctor. For children under 12 years of age, it is recommended to seek medical advice before use.

In patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Crane Safety Hydrocortisone Cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when prescribing this medication to pregnant patients. The absence of data necessitates a careful assessment of the potential risks versus benefits in this population. Women of childbearing potential should be informed of the lack of established safety data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information regarding the use of Crane Safety Hydrocortisone Cream in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be indicated, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this medication is not intended for the treatment of diaper rash. Additionally, patients should be cautioned against using this product in conjunction with any other hydrocortisone products unless they have consulted with a healthcare professional.

Patients should be made aware that if they experience vaginal discharge, they should consult a doctor before using the medication. Furthermore, healthcare providers should instruct patients to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then reappear within a few days. Patients should also be advised to stop use and consult a doctor if they experience rectal bleeding.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging before use; do not utilize any packets that are torn, cut, or opened.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 59º to 86ºF (15º to 30ºC). It is crucial to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Crane Safety 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 Crane Safety 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

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.