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Safeway

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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 5, 2013
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 5, 2013
Manufacturer
Safeway Inc.
Registration number
part348
NDC root
21130-063
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% Cream Plus is a maximum strength cream designed to provide temporary relief from itching associated with minor skin irritations and rashes. It is particularly effective for conditions such as eczema, insect bites, poison ivy, poison oak, and reactions to soaps, detergents, cosmetics, and jewelry. This cream is enriched with vitamins A, D, and E, which can help soothe and nourish the skin.

You can use Hydrocortisone 1% Cream Plus for various types of itching, including seborrheic dermatitis, psoriasis, and external genital and anal itching. However, 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 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. However, if your child is under 2 years old, you should not use this product and should consult a doctor instead.

For treating external anal itching, adults should first clean the affected area with mild soap and warm water, making sure to rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If your child is under 12 years old, it's important to consult a doctor before use.

What to Avoid

You should avoid using this product in your eyes, as it is not safe for that purpose. Additionally, do not insert the product into the rectum using your fingers or any mechanical device or applicator. Following these guidelines is important to ensure your safety and the effectiveness of the product.

Side Effects

You should be aware that this product is for external use only and should not be applied to the eyes or inserted into the rectum using fingers or any devices. If you experience a vaginal discharge, rectal bleeding, or diaper rash, consult your doctor before using it.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, keep this product out of reach of children; 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 using it in your eyes or inserting it into the rectum with fingers or any devices. Before using this product, it's important to consult your doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

While using this product, make sure not to exceed the recommended dosage without consulting your doctor. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and talk to your doctor. Avoid starting any other hydrocortisone product without medical advice. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

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 signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, 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 the safety of hydrocortisone during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus. Hydrocortisone should only be used if it is clearly needed and if the benefits outweigh any risks.

Additionally, dosage adjustments may be necessary, so it's crucial to seek guidance from your healthcare provider. Always use hydrocortisone with caution and under medical supervision during your pregnancy to ensure the best outcomes for you and your baby.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

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 it's safe and appropriate for them. Always prioritize your child's health and safety by seeking professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team 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 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 should be used if you have hepatic impairment (issues with liver function).

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any unforeseen issues.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's validity and safety for use.

Always handle the product with care, and make sure to follow any additional instructions provided to maintain its integrity. If you have any questions about proper usage or disposal, don't hesitate to reach out for guidance.

Additional Information

For adults and children aged 2 years and older, you can apply this product to the affected area up to 3 to 4 times a day. If you are using it for external anal itching, it's best to first cleanse the area with mild soap and warm water, then gently dry it before applying the product. If your child is under 2 years old or if they are under 12 years old and experiencing anal itching, you should consult a doctor before use.

FAQ

What is Hydrocortisone 1% Cream Plus used for?

Hydrocortisone 1% Cream Plus 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 Hydrocortisone 1% Cream Plus?

Adults and children 2 years and older should apply it to the affected area no more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any contraindications for using this cream?

Do not use Hydrocortisone 1% Cream Plus in the eyes or insert it into the rectum using fingers or any device.

What should I do if my condition worsens?

If your condition worsens, persists for more than 7 days, or clears up and occurs again within a few days, stop using the cream and consult a doctor.

Is it safe to use Hydrocortisone 1% Cream Plus during pregnancy?

The safety of this cream during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What should I do if I accidentally swallow the cream?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Can children under 12 years use this cream?

Children under 12 years should consult a doctor before using Hydrocortisone 1% Cream Plus.

What are the side effects of Hydrocortisone 1% Cream Plus?

For external use only, and if you experience any adverse effects, stop use and consult a doctor.

Packaging Info

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

Packaging configurations for Safeway.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% Cream Plus contains 1% hydrocortisone as the active ingredient, providing antipruritic properties for the relief of itching and rashes. This formulation is enriched with 12 moisturizers and vitamins A, D, and E, enhancing its skin-soothing capabilities. The product is presented in a cream dosage form, with a net weight of 1 ounce (28.4 grams). The National Drug Code (NDC) for this product is 21130-063-02. It is comparable to the active ingredient found in Cortizone 10® Plus and Cortaid® Intensive Therapy.

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. For external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, ensuring 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.

The use of this product is not recommended for children under 2 years of age; consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the eyes due to the potential for irritation or damage to ocular tissues. Additionally, it should not be administered rectally, either manually or with any mechanical device or applicator, as this may lead to adverse effects or complications.

Warnings and Precautions

For external use only. This product is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Healthcare professionals should advise patients to consult a doctor prior to use if they experience any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash.

During the use of this product, it is imperative to adhere to the recommended dosage. Patients should be cautioned against exceeding this dosage without prior consultation with a healthcare provider.

Patients must be instructed to 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 important to note that patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional.

Additionally, 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 without delay.

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.

Patients are advised to consult a doctor prior to use if they experience a vaginal discharge, rectal bleeding, or diaper rash. If the condition worsens, persists for more than 7 days, or resolves only to recur within a few days, patients should discontinue use and seek medical advice. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, 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.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Safeway.
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 medication is not recommended, and 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 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 safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, hydrocortisone should only be used if clearly needed and if the benefits outweigh the risks.

Dosage adjustments may be necessary for pregnant patients, and it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Special precautions should be taken, and hydrocortisone should be used with caution and under medical supervision during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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

Healthcare providers should instruct patients to discontinue use 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 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

Patients aged 2 years and older are advised to 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 should cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application. For children under 12 years of age, consultation with a doctor is recommended before use.

Drug Information (PDF)

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