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Pharmaskincare Acnecare 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
68062-9108
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

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 for 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 noted risks of 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.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to 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 to consult your doctor before using any hydrocortisone product in such cases.

Additionally, do not use this product for treating diaper rash; please consult a 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. Remember, timely intervention can make a significant difference.

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 physician before using this medication, as there may be potential risks to your fetus that are not clearly defined.

If your doctor determines that hydrocortisone is necessary, they may recommend dosage adjustments to ensure your safety and that of your baby. Always use this medication only if it is clearly needed and if the benefits outweigh the risks. Your healthcare provider will help guide you through these considerations.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it 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 and to consult a physician (doctor) for advice.

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

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it's especially important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the appropriate dosage based on individual health needs. 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 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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F). It’s okay if the temperature occasionally ranges from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light, as exposure can affect its quality. When not in use, always keep the tube tightly closed to maintain its integrity. Remember to discard the product after opening to ensure 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 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 postmarketing experiences related to this medication.

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 no 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.

Can I use this product if I am pregnant?

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

What should I do if I accidentally ingest this product?

Keep this product out of reach of children. If ingested, seek medical attention immediately.

How should I store this product?

Store it at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep the tube tightly closed when not in use.

Is there any information regarding use in nursing mothers?

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

Packaging Info

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

Packaging configurations for Pharmaskincare Acnecare Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pharmaskincare Acnecare is a topical formulation designed for the management of acne. The product is presented in a cream dosage form, characterized by its soothing properties. The formulation is designed to alleviate skin irritation associated with acne while promoting a clearer complexion. The specific inactive ingredients and their concentrations are proprietary to the formulation. The product is intended for external use only and should be applied as directed.

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 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 intended for the treatment of diaper rash; therefore, a physician should be consulted for appropriate management in such cases.

Additionally, it is crucial 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.

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 and consult a physician before resuming any hydrocortisone product. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a physician.

As a precaution, this product should be kept 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 known 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 Acnecare Cream (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pharmaskincare Acnecare 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 use of this medication is not recommended, and consultation with a physician is advised. It is important to keep the medication out of reach of children to ensure safety.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients, particularly those aged 65 and older.

Due to the lack of clinical data, it is advisable to closely monitor geriatric patients for any adverse effects or changes in efficacy. Additionally, consideration should be given to potential age-related physiological changes that may affect drug metabolism and clearance.

Healthcare providers are encouraged to assess the individual needs and health status of elderly patients when determining the appropriate dosage and treatment regimen.

Pregnancy

The safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician prior to use. Potential risks to the fetus are not clearly defined; therefore, caution is advised when considering treatment. Dosage adjustments may be necessary, and healthcare professionals should provide guidance on appropriate dosing. Hydrocortisone should only be used if clearly needed, and the benefits must outweigh the risks involved.

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

There is no specific information available 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 advisable in this patient population.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 provided data.

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 tube format, with specific storage and handling requirements to ensure its integrity and efficacy. 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).

To maintain product quality, it is essential to protect the tube from light exposure. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and degradation. It is important to note that the product should be discarded after opening to ensure safety and effectiveness.

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 Acnecare 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 Acnecare 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.