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Publix

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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 1995
Label revision date
July 8, 2025
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 1995
Label revision date
July 8, 2025
Manufacturer
Publix Super Markets Inc
Registration number
M017
NDC root
41415-047
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

Publix hydrocream is a topical cream that contains 1% hydrocortisone, which is an anti-itch medication. It is designed to provide temporary relief from itching and rashes caused by various skin irritations, including eczema, insect bites, and reactions to plants like poison ivy, as well as irritations from soaps, detergents, cosmetics, and jewelry. The cream also includes aloe, which can help soothe the skin.

This product is intended for use on minor skin issues and can be helpful for conditions such as seborrheic dermatitis, psoriasis, and external genital and anal itching. However, it's important to use it 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 and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor 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 this medication to the affected area up to 3 to 4 times a day. Before applying, it's best to clean the area with mild soap and warm water, then rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this product without consulting a doctor. Additionally, if your child is under 12 years of age, it's important to speak with a doctor before use to ensure safety and proper guidance.

What to Avoid

It’s important to use this product safely and effectively. You should never apply it to your eyes, as this can cause serious harm. Additionally, avoid using it rectally, whether by hand or with any device, as this is not an appropriate method of application.

By following these guidelines, you can help prevent misuse and ensure that you are using the product as intended. If you have any questions or concerns about how to use this product, please consult a healthcare professional for guidance.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes or inserting it into the rectum. If you experience any vaginal discharge, rectal bleeding, or diaper rash, consult a doctor before using the product.

If your condition worsens, does not improve after 7 days, or clears up only to return shortly after, stop using the product and seek medical advice. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage. If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using it and contact your doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, 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. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the product information. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor are there any stated risks to the fetus. However, since there is no detailed information about safety concerns during pregnancy, it's always a good idea to consult with your healthcare provider before using any medication. They can provide personalized advice based on your health and pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution and seek professional advice to ensure the safety of both you and your baby.

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 not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old, it's best to check with a doctor before use to ensure safety and proper dosage. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When considering the use of Publix Hydrocream (hydrocortisone cream) for older adults, it's important to note that there is no specific information available regarding its use in this age group. This means that while the cream may be safe for many older individuals, there are no established guidelines or dosage recommendations specifically tailored for seniors.

If you are caring for an older adult who may need this treatment, it's wise to consult with a healthcare professional before use. They can provide personalized advice based on the individual's health status and any other medications they may be taking. Always prioritize safety and ensure that any treatment aligns with the unique needs of older adults.

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 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).

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

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. This helps maintain its effectiveness. Additionally, you should check the carton or tube crimp for important information such as the lot number and expiration date, which are essential for tracking and ensuring the product is still safe to use.

Always handle the product with care, and make sure to follow any specific instructions provided for its use. Proper storage and attention to these details will help you use the product safely and effectively.

Additional Information

You should apply this product topically to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are under 2 years old, do not use this product without consulting a doctor. For external anal itching, adults are advised to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the product. If the user is a child under 12 years old, it's best to consult a doctor before use.

FAQ

What is Publix hydrocream used for?

Publix hydrocream is used for temporary relief of itching associated with minor skin irritations and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I apply Publix hydrocream?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using Publix hydrocream?

Do not use Publix hydrocream in the eyes or by putting it into the rectum using fingers or any mechanical device.

What should I do if my condition worsens while using this product?

Stop use and consult a doctor if your condition gets worse, persists for more than 7 days, or clears up and occurs again within a few days.

Is Publix hydrocream safe to use during pregnancy?

The insert does not provide specific information regarding the safety of using Publix hydrocream during pregnancy, so consult a doctor for advice.

Can nursing mothers use Publix hydrocream?

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

What should I do if I accidentally swallow Publix hydrocream?

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

How should I store Publix hydrocream?

Store Publix hydrocream at room temperature and check the carton or tube crimp for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Publix.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Publix hydrocream contains 1% hydrocortisone as its active ingredient, indicated for antipruritic (anti-itch) use. This formulation is designed to provide effective relief from itching and rashes, enhanced with aloe. The product is presented in a dosage form of a cream, with a net weight of 1 ounce (28.4 grams).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital 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. Prior to application, it is recommended that the affected area be cleansed 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 product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes due to the potential for irritation or damage to ocular tissues. Additionally, it is contraindicated for rectal administration, whether by manual insertion or through the use of any mechanical device or applicator, as this may lead to adverse effects or complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Prior to use, individuals should consult a healthcare professional if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

While using this product, it is crucial to adhere to the recommended dosage. Consultation with a healthcare provider is advised before exceeding the recommended dosage to avoid potential complications.

Users must discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than seven days, or resolves only to recur within a few days. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

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 is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a healthcare professional if they have a vaginal discharge, rectal bleeding, or diaper rash. During the use of this product, it is important to adhere to the recommended dosage; exceeding this dosage should be discussed with a doctor.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is also recommended that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

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 is advised.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Publix.
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, the use of this medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of Publix Hydrocream (hydrocortisone cream) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Given the lack of targeted studies or data on geriatric use, it is advisable to monitor elderly patients closely for any potential adverse effects or changes in response to treatment. Additionally, consideration should be given to the overall health status and comorbidities of geriatric patients, as these factors may influence the safety and efficacy of the medication.

Healthcare providers are encouraged to use clinical judgment when determining the appropriateness of Publix Hydrocream for elderly patients, including any necessary dose adjustments or increased monitoring for side effects.

Pregnancy

Hydrocortisone cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. Additionally, there is no available data regarding safety concerns related to the use of hydrocortisone cream in pregnant women. Healthcare professionals should consider the lack of specific information when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

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

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the 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 reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

It is important for patients to stop using the product and consult a doctor if their condition worsens, persists for more than 7 days, or resolves only to recur within a few days. Patients should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be advised to consult a doctor before exceeding the recommended dosage. Additionally, patients should be encouraged to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor. In cases of external anal itching, adults are advised to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry the area before application. For children under 12 years, consultation with a doctor is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Publix, 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 Publix, 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.