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Post Peel Protectant

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This product has been discontinued

Active ingredient
Hydrocortisone 7.5 g/100 mL
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 2015
Label revision date
April 21, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 7.5 g/100 mL
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 2015
Label revision date
April 21, 2016
Manufacturer
Vi Medical Products Inc.
Registration number
part348
NDC root
70484-001
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

The Vitality Institute Skin Care System is a post-peel protectant designed to help soothe and relieve itching. This anti-itch cream comes in a 30 mL (1 FL OZ) container and is intended to support your skin's recovery after cosmetic procedures.

While using this product, it's important to consult a doctor if your condition worsens or if symptoms persist for more than seven days. This ensures that you receive the best care tailored to your needs.

Uses

You can use this product as a post-peel protectant, which helps to soothe and protect your skin after cosmetic procedures like chemical peels. It’s also effective as an anti-itch cream, providing relief from itching caused by various skin irritations.

Rest assured, this product does not have any teratogenic effects, meaning it does not cause harm to a developing fetus.

Dosage and Administration

If you are an adult or a child aged 2 years or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a 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. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

When using this medication, it's important to remember that it is for external use only, so you should not ingest it or apply it internally. Additionally, be careful to avoid contact with your eyes, as this could cause irritation or discomfort.

If you experience any unusual reactions or side effects, please consult your healthcare provider for guidance.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas or ingesting it. Be careful to keep it away from your eyes, as contact can cause irritation.

It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. If you experience any unexpected reactions or side effects, stop using the product and consult your doctor for further guidance.

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 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

The safety of hydrocortisone cream during pregnancy has not been established, which means that it’s unclear whether it is safe for you and your developing baby. It is important to know that using this cream is generally not recommended during pregnancy unless your healthcare provider determines that the benefits outweigh any potential risks to your fetus.

If you are pregnant or planning to become pregnant, it’s crucial to consult with your healthcare provider before using hydrocortisone cream. They can help you understand any potential risks and guide you on the best course of action for 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 excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

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. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, do not use this medication without consulting a doctor first. Always prioritize safety and follow these guidelines to ensure your child's well-being.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 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 recommended limits. 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 over 2 years old. If the patient is under 2 years of age, it is important to consult a doctor before use. Always follow these guidelines to ensure safe and effective treatment.

FAQ

What is the Vitality Institute Skin Care System used for?

The Vitality Institute Skin Care System is used as a post peel protectant and anti-itch cream.

How should I apply this product?

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

What should I do if my condition worsens or does not improve?

You should stop using the product and consult a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Are there any warnings I should be aware of?

Yes, this product is for external use only and you should avoid contact with your eyes.

What should I do if the product is swallowed?

Keep it out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it should only be used if the potential benefits outweigh the risks to the fetus.

Can nursing mothers use this product?

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

How should I store this product?

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.

Packaging Info

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

Packaging configurations for Post Peel Protectant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The Vitality Institute Skin Care System includes a Post Peel Protectant formulated as an anti-itch cream. This product is available in a 30 mL (1 FL OZ) dosage form, designed to provide relief and protection following skin peel procedures.

Uses and Indications

This drug is indicated for use as a post-peel protectant and as an anti-itch cream. It is designed to provide relief and protection following dermatological procedures, such as chemical peels, and to alleviate itching associated with various skin conditions.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 2 years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

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

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

In the event of accidental ingestion, immediate medical assistance should be sought. The product must be kept out of reach of children, and if swallowed, healthcare professionals should be contacted or a Poison Control Center should be notified without delay.

No additional general precautions or laboratory tests have been specified.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. Serious adverse reactions have not been reported in clinical trials; however, caution is advised to prevent any potential irritation or adverse effects associated with improper use. Participants in clinical studies were monitored for any adverse reactions, and no significant safety concerns were identified. It is essential for patients to adhere to the recommended usage guidelines to minimize the risk of adverse reactions.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Post Peel Protectant (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Post Peel Protectant.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. However, the use of this medication is not recommended for children under 2 years of age without consulting a doctor.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Its use is contraindicated in pregnant patients unless the potential benefits outweigh the risks to the fetus. There may be potential risks to the fetus associated with the use of hydrocortisone during pregnancy. Therefore, it is essential for pregnant women to consult a healthcare provider before using this product to ensure informed decision-making regarding its use.

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.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 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. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and the necessary steps to take in case of an emergency.

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, any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised not to use the medication without consulting a doctor. 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 Post Peel Protectant, 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 Post Peel Protectant, 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.