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Clinicalm

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2023
Label revision date
December 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2023
Label revision date
December 3, 2024
Manufacturer
CP Skin Health Group, Inc.
Registration number
M006
NDC root
68726-504
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

CliniCalm ®1% is a topical medication designed to provide temporary relief from itching and discomfort caused by minor skin irritations and rashes. This includes conditions such as eczema, psoriasis, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

This product is part of the PCA skin ® line and comes in a convenient 2.1 oz (60g) package, making it easy to apply when you need relief from skin discomfort.

Uses

You can use this medication for the temporary relief of itching and discomfort caused by minor skin irritations and rashes. It is effective for conditions such as eczema, psoriasis, and reactions to insect bites. Additionally, it can help soothe skin irritations from poison ivy, poison oak, and poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

This treatment is designed to provide you with quick relief from these uncomfortable skin issues, allowing you to feel more at ease.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this 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 physician (doctor). Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. You should not use it for treating diaper rash; if you have concerns about this condition, please consult a physician for appropriate advice and treatment options.

Currently, there are no specified contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these guidelines.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult a physician before trying any other hydrocortisone products.

Additionally, do not use this product for diaper rash without consulting a healthcare professional. If you are pregnant or breastfeeding, it's important to ask a health professional before using it. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

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 7 days or return shortly after improvement, stop using the product. Do not start any other hydrocortisone product without consulting your doctor first.

It's important not to use this product for diaper rash; please consult a physician for appropriate treatment. If you are pregnant or breastfeeding, check with a healthcare professional before using this product. Always keep it out of reach of children, and if the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a physician (a medical doctor). Always prioritize your child's safety and well-being by adhering to these recommendations.

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 before starting the medication. 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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. 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 remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 15° and 25°C (59° and 77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

For adults and children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is CliniCalm ®1% used for?

CliniCalm ®1% is used for the temporary relief of itching and discomfort associated with minor skin irritations and rashes due to conditions like eczema, psoriasis, insect bites, and more.

Who can use CliniCalm ®1%?

Adults and children 2 years of age and older can use CliniCalm ®1%. Children under 2 years should not use it without consulting a physician.

How should I apply CliniCalm ®1%?

Apply CliniCalm ®1% to the affected area not more than 3 to 4 times daily.

Are there any contraindications for CliniCalm ®1%?

No specific contraindications are mentioned for CliniCalm ®1%.

What should I do if my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, stop using CliniCalm ®1% and consult a physician.

Can I use CliniCalm ®1% if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using CliniCalm ®1%.

What should I do if CliniCalm ®1% is swallowed?

Keep CliniCalm ®1% out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Is CliniCalm ®1% a controlled substance?

CliniCalm ®1% is not classified as a controlled substance.

What is the storage requirement for CliniCalm ®1%?

Store CliniCalm ®1% at 15°–25°C (59°–77°F).

Packaging Info

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

Packaging configurations for Clinicalm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PCA Skin® CliniCalm® is a topical formulation designed for the management of skin irritation. This product is available in a dosage form of 2.1 oz (60 g). CliniCalm® contains a 1% concentration of its active ingredient, which is specifically formulated to soothe and calm the skin.

Uses and Indications

This drug is indicated for the temporary relief of itching and discomfort associated with minor skin irritations and rashes due to various conditions, including eczema, psoriasis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not 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 product should not be used without consulting a physician. Healthcare professionals are advised to evaluate the necessity and safety of treatment in this age group before proceeding with any application.

Contraindications

The product is contraindicated for the treatment of diaper rash. Consultation with a physician is advised in such cases. No other contraindications have been specified.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

In cases where the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of this product. It is imperative that patients do not initiate the use of any other hydrocortisone product without prior consultation with a physician.

This product is not indicated for the treatment of diaper rash. Patients should be directed to consult a physician for appropriate treatment options in such cases.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional before using this product.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience adverse reactions, which can be categorized based on seriousness and frequency.

Serious adverse reactions include the potential for worsening of the condition being treated. If symptoms persist for more than 7 days or if they clear up and then recur within a few days, patients are advised to discontinue use and consult a physician before using any other hydrocortisone product.

Common adverse reactions are primarily related to improper use of the product. It is important to note that this product is for external use only and should not come into contact with the eyes. Additionally, the product should not be used for the treatment of diaper rash; patients should consult a physician for appropriate treatment in such cases.

In terms of safety during pregnancy or breastfeeding, patients are advised to seek guidance from a health professional before using this product.

Furthermore, to ensure safety, the product should be kept out of reach of children. In the event that the product is swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 Clinicalm (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Clinicalm.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, the use of this 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific product involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients that the product is not intended for the treatment of diaper rash. Patients should be encouraged to consult a physician for appropriate treatment options if they have concerns regarding diaper rash.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 25°C (59° to 77°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Clinicalm, 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 Clinicalm, 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.