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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
January 5, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Gel
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 2017
Label revision date
January 5, 2025
Manufacturer
Hayden Caleel LLC
Registration number
M017
NDC root
60541-1900
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

This medication is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as dermatitis (inflammation of the skin), eczema (a condition that makes the skin red and itchy), and insect bites.

If you are experiencing discomfort from these skin issues, this product may help alleviate your symptoms. However, it's important to consult with a doctor for any other uses to ensure safe and effective treatment.

Uses

If you're dealing with minor skin irritations, inflammation, or rashes, this product can help temporarily relieve the itching. It's effective for conditions like dermatitis, eczema, and insect bites, providing you with some comfort during those uncomfortable moments.

However, it's important to remember that any other uses of this product should only be done under the guidance and supervision of a doctor. Always consult with a healthcare professional if you have questions or concerns about your skin condition.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area. For adults and children aged 2 years and older, it's recommended to use it no more than 3 to 4 times a day.

However, if your child is under 2 years old, it's important not to use this medication without consulting a doctor first. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to diaper rash. Avoid getting it in your eyes, and do not exceed the recommended dosage unless directed by a doctor.

If your condition worsens, persists for more than seven days, or improves and then returns within a few days, stop using the product and consult your doctor. Additionally, do not start any other hydrocortisone product without first speaking to a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes unless directed by a doctor. When applying, be careful not to get it in your eyes, and do not exceed the recommended amount unless your doctor advises you to do so.

If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and consult your doctor. It's important not to start any other hydrocortisone product without first checking with your healthcare provider. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. They can provide the necessary guidance and support. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

Currently, there is no specific information available about the use of GLO SKIN BEAUTY REMEDY GEL during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including skincare items, to ensure they are safe 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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose 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 under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it's always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you or someone you care for is an older adult, be sure to monitor for any unusual side effects or changes in health after starting a new medication, and report these to a healthcare professional promptly.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 feel free to ask questions and share any concerns you may have about your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. Always follow these guidelines to ensure safe and effective treatment.

FAQ

What conditions can this drug help relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to dermatitis, eczema, and insect bites.

How should I use this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Do not use in children under 2 years of age without consulting a doctor.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with the eyes, do not use for diaper rash, and stop use if the condition worsens or symptoms persist for more than 7 days.

What should I do if I accidentally swallow this product?

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

Can I use this product for other conditions?

Other uses of this product should only be under the advice and supervision of a doctor.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed. Discard after opening.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Packaging Info

Below are the non-prescription pack sizes of Glo Skin Beauty Remedy Gel. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glo Skin Beauty Remedy Gel.
Details

Drug Information (PDF)

This file contains official product information for Glo Skin Beauty Remedy Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as dermatitis, eczema, and insect bites.

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

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the use of this medication is not recommended without consulting a healthcare professional. It is advised to seek medical advice before administering this treatment to this age group.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

This product is intended for external use only and is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed to do so by a healthcare provider.

In the event that the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the user must discontinue use and consult a healthcare professional. It is crucial not to initiate the use of any other hydrocortisone product without prior consultation with a doctor.

In cases of accidental ingestion, immediate medical assistance should be sought, or the user should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is for external use only and is not intended for the treatment of diaper rash. It is important to avoid contact with the eyes during application. Patients are advised not to exceed the recommended dosage unless directed by a healthcare professional.

In clinical practice, patients are 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. Additionally, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

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 Glo Skin Beauty Remedy Gel. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glo Skin Beauty Remedy Gel.
Details

Pediatric Use

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

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

There is no specific information available regarding the use of GLO SKIN BEAUTY REMEDY GEL during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients, given the absence of data on potential fetal impacts or associated risks. It is advisable to weigh the benefits against any potential risks when prescribing this product to women of childbearing potential.

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 data 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 information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Glo Skin Beauty Remedy Gel, 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 Glo Skin Beauty Remedy Gel, 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.