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Rite Aid 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 2023
Label revision date
December 12, 2023
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 2023
Label revision date
December 12, 2023
Manufacturer
Rite Aid
Registration number
M017
NDC root
11822-2685
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

This medication is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, seborrheic dermatitis, and psoriasis, as well as reactions to poison ivy, poison oak, and poison sumac. It can also help soothe itching from insect bites and irritations caused by cosmetics, jewelry, detergents, and soaps.

In addition to these uses, this drug is effective for temporarily relieving external anal and genital itching. It's important to consult with a doctor for any other uses beyond those mentioned.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from rashes due to poison ivy, poison oak, and poison sumac, as well as from insect bites. Additionally, if you experience irritation from cosmetics, jewelry, detergents, or soaps, this product may offer relief.

You can also use it to temporarily relieve itching in the external anal and genital areas. However, for any other uses, 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 experiencing discomfort in a specific area, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important to consult a doctor before use.

If you are dealing with external anal itching as an adult, start by gently cleaning the area with mild soap and warm water, making sure to rinse thoroughly. You can also use a suitable cleansing pad. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth before applying the medication. If the affected child is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash or for external genital itching if you have a vaginal discharge—please consult your doctor in these cases. If you experience rectal bleeding, do not use it for external anal itching and seek medical advice immediately.

Additionally, avoid getting the medication in your eyes, and do not exceed the recommended dosage for external anal itching unless directed by your doctor. Never insert the medication into the rectum using your fingers or any device. Following these guidelines will help ensure your safety while using this product.

Side Effects

When using this product, it's important to be aware of certain side effects and precautions. This medication is for external use only and should not be applied to diaper rash or used for external genital itching if you have a vaginal discharge. If you experience external anal itching and notice rectal bleeding, consult a doctor immediately. Avoid getting the product in your eyes, and do not use it more than directed for external anal itching unless advised by a doctor.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and return shortly after, stop using the product and consult a doctor. Keep this medication 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 that are not specified. Do not use it for treating diaper rash, external genital itching with vaginal discharge, or external anal itching if you notice rectal bleeding—consult a doctor in these cases.

If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and contact your doctor. It's important not to start any other hydrocortisone product without guidance.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. Always keep this product out of reach of children to ensure their safety.

Overdose

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

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of Rite Aid Hydrocortisone 1% ointment during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this ointment on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter products like this ointment. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, you can use hydrocortisone 1% ointment without specific warnings or recommendations against it. The information available does not indicate any concerns about its use while nursing or any potential effects on breast milk.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. If your child is experiencing external anal itching and is under 12 years old, please seek advice from a doctor as well. Always prioritize your child's safety and well-being by following these guidelines.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 situation. They can help you understand any necessary precautions or adjustments 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 (issues with liver function).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20ºC to 25ºC (68ºF to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I use this drug?

Adults and children 2 years and over 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 this drug?

No specific contraindications are mentioned in the provided text.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition gets worse, or if symptoms last for more than 7 days or recur within a few days.

Can I use this drug for diaper rash?

No, do not use this drug for the treatment of diaper rash; consult a doctor instead.

What should I do if I accidentally swallow the drug?

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

Is this drug safe to use during pregnancy?

There is no specific information regarding the safety of this drug during pregnancy in the provided text.

Can nursing mothers use this drug?

The insert does not provide specific warnings or recommendations regarding the use of this drug in nursing mothers.

What are the storage conditions for this drug?

Store the drug at 20ºC to 25ºC (68ºF to 77ºF).

What should I avoid while using this drug?

Do not get the drug in your eyes, and do not use it more than directed unless advised by a doctor.

Packaging Info

Below are the non-prescription pack sizes of Rite Aid Hydrocortisone (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rite Aid Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a hydrocortisone ointment containing 1% hydrocortisone as the active ingredient. It is formulated as a white to off-white, smooth, and homogenous preparation. Inactive ingredients include aloe barbadensis leaf extract, benzyl alcohol, cetyl alcohol, dimethicone, glycerin, mineral oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E), and triethanolamine. The SPL Code for this product is 34089-3.

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, seborrheic dermatitis, poison ivy, poison oak, poison sumac, psoriasis, insect bites, and reactions to cosmetics, jewelry, detergents, and soaps.

Additionally, this drug provides temporary relief from external anal and genital 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 recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal itching in adults, it is recommended that, when practical, the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before the application of the product.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

The product is contraindicated in the following situations:

  • The treatment of diaper rash is not recommended; consult a healthcare professional for appropriate alternatives.

  • Use is contraindicated for external genital itching in the presence of vaginal discharge; a doctor should be consulted.

  • External anal itching treatment is contraindicated if rectal bleeding occurs; prompt consultation with a healthcare provider is necessary.

  • Contact with the eyes must be avoided.

  • Do not exceed the recommended dosage for external anal itching unless directed by a healthcare professional.

  • The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for such conditions. Additionally, it should not be used for external genital itching in the presence of vaginal discharge or for external anal itching if rectal bleeding occurs; in these cases, prompt medical consultation is recommended.

Patients should be instructed to discontinue use and seek medical advice if their 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 note that patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

To ensure safety, this product must be kept out of reach of children.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals should consult a doctor before use if they have external genital itching accompanied by vaginal discharge or external anal itching with rectal bleeding.

While using this product, it is important to avoid contact with the eyes. For external anal itching, patients should adhere strictly to the directed dosage and should not exceed this amount unless advised by a healthcare professional. Additionally, the product should not be inserted 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. It is also recommended that patients refrain from initiating the use of any other hydrocortisone product during this time.

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 should be made.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Rite Aid Hydrocortisone (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rite Aid Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. 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 in children under 12 years, it is advised to seek guidance from a healthcare provider.

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 is no specific information available regarding the use of Rite Aid Hydrocortisone 1% ointment during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when treating pregnant patients with this ointment.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone 1% ointment in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or the potential for excretion of hydrocortisone in breast milk.

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, 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 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. Instruct patients that if the product is swallowed, they should seek medical help 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, they should be cautioned against using the product for external genital itching if they have a vaginal discharge, and to seek medical advice in such cases.

For patients experiencing external anal itching, it is important to advise them not to use the product if rectal bleeding occurs and to consult a doctor promptly. Patients should also be instructed to stop using the product and seek medical advice 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 be reminded not to begin the use of any other hydrocortisone product without consulting a healthcare professional.

While using this product, patients should be cautioned to avoid contact with the eyes. For those using the product for external anal itching, it is essential to emphasize that they should not exceed the directed dosage unless instructed otherwise by a doctor. Furthermore, patients 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 upon request. It should be stored at a controlled room temperature of 20ºC to 25ºC (68ºF to 77ºF). Care should be taken to ensure that the storage environment maintains these temperature conditions to preserve product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rite Aid 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 Rite Aid 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.