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Theraplex Aim Anti-Itch Moisturizing

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Active ingredient
Hydrocortisone 10 mg/1 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 2024
Label revision date
April 27, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2024
Label revision date
April 27, 2024
Manufacturer
THERAPLEX, LLC
Registration number
M017
NDC root
82280-478
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

This medication is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for various skin conditions, including eczema (a condition that makes the skin red and itchy), seborrheic dermatitis (a type of skin rash), and psoriasis (a chronic skin condition that causes rapid skin cell production). Additionally, it can help alleviate itching related to reactions from soaps, detergents, and cosmetics.

While this product can be effective for these conditions, it's important to use it under the advice and supervision of a doctor for any other uses. This ensures that you receive the most appropriate care for your specific situation.

Uses

This product is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful if you’re dealing with conditions like eczema, seborrheic dermatitis, psoriasis, or reactions to soaps, detergents, or cosmetics.

For any other uses, it’s important to consult with your doctor to ensure it’s appropriate for your situation.

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 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 your doctor 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

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and do not use it for diaper rash without consulting a doctor. If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may come into contact with your eyes. If you notice that your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. It's also important not to start using any other hydrocortisone product without first speaking to your healthcare provider.

In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center immediately. Your safety is a priority, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

Currently, there is no information available about the use of THERAPLEX AIM Anti-Itch Moisturizing Cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or creams you consider using during this time.

Lactation Use

Currently, there is no specific information available about the use of THERAPLEX AIM Anti-Itch Moisturizing Cream for nursing mothers or during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize your health and your infant's well-being when considering any new products while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and 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 issues, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep them informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to talk to your healthcare provider before starting any new medications, especially if you're considering using another hydrocortisone product. This is to ensure that it’s safe and appropriate for your situation. Your doctor can help you understand any potential interactions and guide you on the best course of action.

Currently, there are no specific interactions noted with laboratory tests, but maintaining open communication with your healthcare provider about all medications and tests is always a good practice. This way, you can ensure your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid 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 should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What conditions does this drug help relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

How should I use this drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it without consulting a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned, but do not use it for the treatment of diaper rash without consulting a doctor.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center right away.

What precautions should I take when using this drug?

Avoid contact with eyes, and stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is this drug safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of this drug during pregnancy or lactation.

What should I do if I need to use another hydrocortisone product?

Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

What is the storage requirement for this drug?

Store the drug at 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Theraplex Aim Anti-Itch Moisturizing (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraplex Aim Anti-Itch Moisturizing.
Details

Drug Information (PDF)

This file contains official product information for Theraplex Aim Anti-Itch Moisturizing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

There are no 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 unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

The product is contraindicated for the treatment of diaper rash. Consultation with a healthcare professional is advised for appropriate management in such cases.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes when using this product to prevent irritation or injury.

Patients are instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is essential that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and consultation with a healthcare professional is advised in such cases.

During the use of this product, patients should avoid contact with the eyes. If the condition being treated worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a doctor. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

It is important to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Theraplex Aim Anti-Itch Moisturizing (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraplex Aim Anti-Itch Moisturizing.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; caregivers are advised to consult a physician for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of THERAPLEX AIM Anti-Itch Moisturizing Cream during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product during pregnancy.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for THERAPLEX AIM Anti-Itch Moisturizing Cream. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to consult a healthcare provider for the treatment of diaper rash to ensure appropriate care.

Patients should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should not start using any other hydrocortisone product without first consulting a doctor. Additionally, patients should be cautioned to avoid contact with their eyes to prevent irritation or injury.

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 controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is advised that clinicians do not use this medication in children under 2 years of age without consulting a doctor. 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 Theraplex Aim Anti-Itch Moisturizing, 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 Theraplex Aim Anti-Itch Moisturizing, 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.