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Pharmaskincare Multi-Gly Skin Relief Cream

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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
68062-9106
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 provide temporary relief from itching caused by minor skin irritations and rashes. It works by soothing the affected area, helping to alleviate discomfort and promote healing. If you have any other uses in mind, it's important to consult with a physician for guidance and supervision.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations and rashes. It's important to remember that if you have other uses in mind, you should consult with a physician for advice and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, and there are also no nonteratogenic effects reported. Always prioritize your health and safety by following professional guidance when using any medication.

Dosage and Administration

If you are an adult or a child aged two years or older, you can apply this 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 the guidance provided by your healthcare professional and use the medication 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 your doctor before using any hydrocortisone products.

Additionally, this product should not be used for treating diaper rash. Always keep it 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 the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel concerned, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the situation, including what substance was taken and how much. Remember, acting quickly can make a significant difference in ensuring your safety and well-being.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that this product has not been evaluated for safety during pregnancy. You should consult your physician before using it, as the potential risks to your fetus have not been established. Caution is advised, and you should only use the product if it is clearly needed and after discussing it with your healthcare provider.

There are no specific dosage modifications provided for pregnant individuals, so it's essential to seek guidance from your physician regarding the appropriate use. Always prioritize your health and the health of your baby by having open conversations with your healthcare team.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If you have a child who is two years old or older, you can apply this 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 seek professional advice when it comes to their health.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how to manage 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°C to 25°C (68°F to 77°F). It's important to protect it from light, so keep it in its original packaging or a dark container. Always make sure the container is tightly closed to maintain its integrity.

Once you open the container, please remember to discard any remaining product after use to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and maintain its quality.

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 your child is under two years old, do not use this medication without consulting a physician first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this product?

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

How should I apply this product?

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

Can children under two years of age use this product?

No, do not use this product on children under two years of age; consult a physician instead.

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 product safe to use during pregnancy?

The product has not been evaluated for safety during pregnancy, so consult a physician before use if you are pregnant or planning to become pregnant.

What should I do if I experience side effects?

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

How should I store this product?

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

Are there any contraindications for using this product?

Consult a physician before use if you are pregnant, planning to become pregnant, or if you have any specific health concerns.

Packaging Info

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

Packaging configurations for Pharmaskincare Multi-Gly Skin Relief Cream.
Details

Drug Information (PDF)

This file contains official product information for Pharmaskincare Multi-Gly Skin Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be undertaken only under the advice and supervision of a physician.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 is limited to the specified 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 individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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.

Additionally, it is essential to keep this product 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.

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 any hydrocortisone product in such cases.

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

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Pharmaskincare Multi-Gly Skin Relief Cream (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pharmaskincare Multi-Gly Skin Relief 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. Therefore, pregnant patients or those planning to become pregnant should consult a physician before use. The potential risks to the fetus are not established, and caution is advised when considering the use of this product in pregnant individuals. No specific dosage modifications for pregnant individuals are provided; healthcare providers should be consulted for guidance on appropriate use. It is recommended that the product be used only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

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 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 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 toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment 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 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. For adults and children aged two years and older, it should be applied to the affected area no more than three to four times daily. It is contraindicated for use in children under two years of age, and a physician should be consulted for this age group.

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 Pharmaskincare Multi-Gly Skin Relief 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 Multi-Gly Skin Relief 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.