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Pharmaskincare Brightening Dermarelief Cream

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Hydrocortisone 0.025 mg/2.5 mL
Other brand names
Dosage form
Lotion
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
October 11, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.025 mg/2.5 mL
Other brand names
Dosage form
Lotion
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
October 11, 2017
Manufacturer
Spa de Soleil
Registration number
part348
NDC root
68062-9103
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

You can use this medication for the temporary relief of itching caused by minor skin irritations and rashes. It is designed to help soothe discomfort and provide a sense of relief when you experience these common skin issues. Always consult with a physician for any other uses or if you have questions about your specific situation.

Uses

If you're dealing with minor skin irritations or rashes, this product can provide temporary relief from itching. It's designed to help soothe discomfort and make your skin feel more comfortable.

However, for any other uses beyond this, it's important to consult with a physician. They can provide guidance and ensure that you're using the product safely and effectively.

Dosage and Administration

If you are an adult or a child aged two years and older, you can apply the medication to the affected area up to three or four times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under two years old, it’s important not to use this medication without first consulting a physician (doctor). Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

You may experience some side effects when using this product. It is important to note that this medication is for external use only, and you should avoid contact with your eyes. If your condition worsens or symptoms persist for more than seven days, or if they clear up and then return within a few days, stop using the product and consult a physician before using any hydrocortisone products. Additionally, this product should not be used for treating diaper rash.

Always keep this medication out of reach of children to ensure their safety.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. If your condition worsens or if symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product. It's important not to start using any hydrocortisone product without first consulting your doctor.

Additionally, do not use this product for diaper rash; please consult your physician for appropriate treatment. Always keep this product out of reach of children to ensure their safety.

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 if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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. Therefore, it is generally not recommended to use this medication unless your doctor specifically advises you to do so. There may be potential risks to your developing baby, so consulting with your physician before using hydrocortisone is crucial.

Additionally, if you are prescribed this medication while pregnant, your doctor may need to adjust the dosage to ensure safety. Always seek guidance from your healthcare provider to make informed decisions about your health and the health of 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 passed into breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child who is two years old or older, you can apply the medication to the affected area up to three or four times a day. However, if your child is under two years old, it’s important not to use this medication without first consulting a physician (a medical doctor). 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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may need to be adjusted or monitored based on your liver function.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have concerns about your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions between this medication and other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

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 important to protect it from light, so keep it in its original container and make sure that the container is tightly closed when not in use. Once you open the container, please remember to discard any remaining product after use to maintain safety and effectiveness.

Additional Information

You should apply this medication topically to the affected area, using it no more than three or four times a day if you are an adult or a child aged two years and older. If the patient is under two years of age, it is important to consult a physician before use.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of itching associated with minor skin irritations and rashes.

How should I apply this drug?

Adults and children two years of age and older should apply it to the affected area not more than three or four times daily. Children under two years of age should not use it and should consult a physician.

Are there any warnings I should be aware of?

Yes, this product is for external use only, and you should avoid contact with the eyes. If your condition worsens or persists for more than seven days, consult a physician.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is not recommended unless directed by a physician due to potential risks to the fetus.

What should I do if I experience side effects?

If you experience side effects or if your condition worsens, stop using the product and consult a physician.

How should I store this drug?

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

Can I use this drug for diaper rash?

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

What should I do if I have questions about using this drug?

For any questions or concerns, especially regarding other uses, consult a physician for advice and supervision.

Packaging Info

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

Packaging configurations for Pharmaskincare Brightening Dermarelief Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pharmaskincare Brightening Dermarelief is a topical formulation designed for skin brightening and relief. The product is presented in a suitable dosage form for dermatological application. The associated image for reference is titled "Pharmaskincare Brightening Dermarelief.jpg." Further details regarding its chemical composition, molecular weight, and inactive ingredients are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes.

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under two years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a physician for appropriate alternatives or guidance.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. There are no other contraindications listed for this product.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens or symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued immediately. Prior to resuming any hydrocortisone product, consultation with a physician is strongly advised.

This product is not indicated for the treatment of diaper rash; therefore, a physician should be consulted for appropriate management in such cases.

To ensure safety, this product must be kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only, and contact with the eyes should be avoided to prevent irritation or injury.

In clinical practice, if the condition worsens or symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use of the product. Consultation with a physician is recommended before resuming the use of any hydrocortisone product in such cases.

Additionally, this product should not be used for the treatment of diaper rash. Care should be taken to keep the product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Pharmaskincare Brightening Dermarelief Cream.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three or four times daily. For children under two years of age, the medication is not recommended, and consultation with a physician is advised.

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

The safety of hydrocortisone during pregnancy has not been established. The use of this product is not recommended during pregnancy unless directed by a physician. There may be potential risks to the fetus; therefore, it is essential for healthcare providers to consult with a physician before use. Additionally, dosage adjustments may be necessary for pregnant individuals, and healthcare professionals should seek guidance on appropriate dosing in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are crucial in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage scenarios.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged two years and older being three to four times daily to the affected area. For children under two years of age, use is not advised without consulting a physician. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pharmaskincare Brightening Dermarelief Cream, 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 Pharmaskincare Brightening Dermarelief Cream, 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.