Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Premier Value

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 1989
Label revision date
March 2, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 1989
Label revision date
March 2, 2018
Manufacturer
Pharmacy Value Alliance LLC
Registration number
part348
NDC root
68016-063
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone 1% is a cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be effective for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as insect bites and irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it helps relieve external anal and genital itching.

This cream contains Plus12 Moisturizers, which can help soothe and hydrate the skin while alleviating discomfort. It is classified as an antipruritic (anti-itch) product, making it a useful option for managing various skin irritations.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. For any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

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

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person using the medication is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid using more than the recommended amount unless directed by your doctor, and do not insert it directly into the rectum using fingers or any device.

If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult your doctor. While using this product, be careful to avoid contact with your eyes. Always prioritize your health and seek professional advice when needed.

Side Effects

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

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

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of hydrocortisone during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using hydrocortisone, you should discuss it with your healthcare provider to understand any potential risks and to ensure that you are making the best decision for your health and your baby's health. Always prioritize open communication with your doctor regarding any medications during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. For children under 12 years old, you should also seek advice from a doctor before use. Always prioritize your child's safety and well-being by following these guidelines.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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. This means that there are no tailored recommendations for how your kidney condition might affect the use of this medication.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. 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, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25° C (68° to 77° F). It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you keep track of the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any questions about disposal or specific safety measures, please refer to the product guidelines or consult a healthcare professional.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, adults should also follow the same application frequency. Always ensure you are using the medication as directed for the best results.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% cream temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone 1%?

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

Can I use Hydrocortisone 1% for diaper rash?

No, do not use Hydrocortisone 1% for the treatment of diaper rash. Consult a doctor instead.

What should I do if my condition worsens?

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

Are there any precautions I should take when using this product?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum.

Is it safe to use Hydrocortisone 1% during pregnancy?

The insert does not provide specific information regarding the use of Hydrocortisone during pregnancy. Consult your doctor for advice.

What should I do if I swallow Hydrocortisone 1%?

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

How should I store Hydrocortisone 1%?

Store Hydrocortisone 1% at 20° to 25° C (68° to 77° F).

Packaging Info

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

Packaging configurations for Premier Value.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% is a topical cream formulated to provide antipruritic effects, specifically targeting itch and rash relief. The product contains Plus12 Moisturizers to enhance skin hydration. Each container has a net weight of 1 oz (28.4 g). The formulation has undergone independent testing to ensure quality and efficacy.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this drug provides temporary relief for external anal and genital itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

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

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted in such cases.

The product must not be administered rectally using fingers, mechanical devices, or applicators. Furthermore, it is essential to adhere to the recommended dosage and not exceed it unless directed by a healthcare provider.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. It is also not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes during application. The product should not be used in greater amounts than directed unless specifically advised by a physician. Direct insertion into the rectum using fingers, mechanical devices, or applicators is contraindicated.

Patients must be advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, the use of any other hydrocortisone product should not commence without prior consultation with a healthcare provider.

In the event of rectal bleeding, patients should stop use immediately and seek medical attention. It is imperative to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients should consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without medical advice.

During the use of this product, patients are advised to avoid contact with the eyes and to adhere strictly to the directed dosage unless otherwise instructed by a healthcare professional. It is important not to apply the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, patients must stop using the product and consult a doctor.

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

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Premier Value.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the medication is indicated for use in adults and children aged 2 years and older, with a recommended application of not more than 3 to 4 times daily to the affected area. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. The same frequency of application, not more than 3 to 4 times daily, applies. For children under 12 years of age, it is recommended to seek medical advice before use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of hydrocortisone during pregnancy. Consequently, the safety of hydrocortisone in pregnant patients has not been established, and there are no documented dosage modifications or special precautions recommended for this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone in women of childbearing potential. It is advisable to monitor pregnant patients closely and to discuss any concerns regarding treatment options with them.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to communicate that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Patients should 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.

If patients experience rectal bleeding, they should stop using the product and seek medical attention. It is crucial to remind patients to avoid contact with their eyes while using this product.

Furthermore, patients should be cautioned not to exceed the directed dosage unless specifically instructed to do so by a healthcare professional. They should also be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25° C (68° to 77° F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date, which are essential for tracking and quality assurance. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily.

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 Premier Value, 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 Premier Value, 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.