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Maximum Strength Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
January 7, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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 2013
Label revision date
January 7, 2026
Manufacturer
DLC Laboratories, Inc
Registration number
M017
NDC root
24286-1560
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

De La Cruz Anti-Itch Ointment is a maximum strength hydrocortisone (a type of medication that reduces inflammation) ointment designed to provide temporary relief from itching caused by minor skin irritations, rashes, and inflammation. It can help soothe discomfort associated with conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and even external genital, feminine, and anal itching.

This ointment is fragrance-free and offers rapid relief, making it a convenient option for managing various skin irritations. However, it's important to use it as directed and consult a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including inflammation and rashes. You can use it for discomfort related to conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

Additionally, this product is suitable for alleviating itching in external genital areas, as well as feminine and anal itching. If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

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

If you have a child under 2 years old, do not use this medication without first consulting a doctor. Additionally, if the patient is a child under 12 years old and is experiencing external anal itching, it’s important to speak with a doctor before use. Always follow these guidelines to ensure safe and effective treatment.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or for external feminine itching if you have a vaginal discharge—please consult your doctor in these cases. Additionally, avoid using this product if you experience rectal bleeding, and stop using it if your condition worsens or if symptoms persist for more than 7 days, or if they clear up and then return shortly after. Always consult your doctor before starting any other hydrocortisone product.

While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your doctor. Never insert this product into the rectum using your fingers or any device. Your safety is a priority, so please follow these guidelines closely.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return shortly after. Additionally, if you experience rectal bleeding, seek medical advice immediately.

This product is for external use only and should not be used for diaper rash or external feminine itching if you have a vaginal discharge. Always avoid contact with your eyes, and do not use more than directed unless advised by a doctor. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid using it on areas like diaper rashes or for feminine itching if you have a vaginal discharge—consult your doctor instead. When using this 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 fingers or any device.

If your condition worsens, symptoms last more than 7 days, or if they clear up 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. Always keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help right away.

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

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, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

You can use hydrocortisone ointment during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this ointment is contraindicated (not recommended) for pregnant individuals, nor does it state any known risks to the fetus associated with its use.

However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being 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 aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, please consult a doctor before use.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so don't hesitate to reach out to a healthcare professional with any questions or concerns.

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, it’s important to consult with a healthcare provider for personalized advice. 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 to ensure safe and effective treatment.

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 based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage.

If you have any components that come with the product, make sure to keep them in a clean and safe environment. Proper storage and careful handling are key to ensuring that everything works as intended.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. It's important to stop using the product and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. Avoid starting any other hydrocortisone product without first talking to your doctor.

Keep this medication out of the reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is De La Cruz Anti-Itch Ointment used for?

De La Cruz Anti-Itch Ointment is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

Who should not use this product?

Do not use this product for children under 2 years of age, for the treatment of diaper rash, or for external feminine itching if you have a vaginal discharge without consulting a doctor.

How should I apply De La Cruz Anti-Itch Ointment?

Adults and children 2 years of age and older should apply the ointment to the affected area not more than 3 to 4 times daily.

What should I do if my condition worsens?

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

Can I use this ointment during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy, so consult a doctor before use.

Is it safe to use while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What precautions should I take when using this ointment?

Avoid contact with the eyes, do not use more than directed unless told to do so by a doctor, and do not put this product into the rectum.

What should I do if I accidentally swallow the ointment?

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

What are the additional features of this ointment?

De La Cruz Anti-Itch Ointment is fragrance-free and provides rapid relief.

Packaging Info

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

Packaging configurations for Maximum Strength Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength 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 irritations, inflammation, and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis. Additionally, it is indicated for the relief of external genital, feminine, and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For adults specifically addressing external anal itching, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is also necessary to consult a doctor before use.

Contraindications

The product is contraindicated in the following situations:

  • The treatment of diaper rash is not recommended; consultation with a healthcare professional is advised.

  • External feminine itching should not be treated if accompanied by vaginal discharge; a healthcare professional should be consulted.

Due to the potential for adverse effects, it is essential to adhere to these contraindications to ensure patient safety.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for external feminine itching if there is a vaginal discharge; again, consultation with a healthcare provider is recommended.

When using this product, it is imperative to avoid contact with the eyes. Patients should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare professional. Furthermore, this product should not be administered rectally using fingers, mechanical devices, or applicators.

Patients should 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 prior consultation with a healthcare provider. Immediate medical attention should be sought if rectal bleeding occurs.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash and external feminine itching in the presence of vaginal discharge; in such cases, consultation with a healthcare professional is advised.

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. Additionally, patients should refrain from inserting the product 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 resolve and then recur within a few days. Immediate medical attention should be sought if rectal bleeding occurs.

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 without delay.

Drug Interactions

There are currently no documented drug interactions associated with 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 Maximum Strength Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Hydrocortisone.
Details

Pediatric Use

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

In cases of external anal itching, children under 12 years of age should also consult a doctor prior to use. It is crucial to keep this medication out of the reach of children. If ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone ointment may be used during pregnancy as there are no specific warnings, precautions, or dosage modifications indicated in the available prescribing information. The insert does not provide any contraindications for use during pregnancy, nor does it specify any known risks to the fetus associated with its application. However, healthcare professionals should consider the overall clinical context and individual patient circumstances when recommending this treatment to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals should exercise caution when recommending this product to nursing mothers.

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 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, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. Additionally, it should not be used for external feminine itching if there is a vaginal discharge; a consultation with a healthcare professional is recommended in such cases.

Patients must 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 start using any other hydrocortisone product without first consulting a doctor.

It is important to inform patients to stop using the product and seek medical advice if they experience rectal bleeding. While using this product, patients should be cautioned to avoid contact with the eyes.

Patients should be reminded not to exceed the directed dosage unless specifically instructed to do so by a healthcare provider. Furthermore, they should be advised against inserting the product 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 room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients 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 avoid the use of any other hydrocortisone products without prior consultation with a healthcare provider.

Additionally, patients should be reminded to keep the product out of the reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Maximum Strength 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 Maximum Strength 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.

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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.