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Makesense

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
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 2014
Label revision date
August 8, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
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 2014
Label revision date
August 8, 2016
Manufacturer
Cherry Hill Sales Co
Registration number
part348
NDC root
69020-204
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 provides temporary relief from itching caused by various minor skin irritations and rashes. It is particularly effective for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. Additionally, it can help alleviate itching related to soaps, detergents, cosmetics, and jewelry.

You may also find this product useful for temporarily relieving external anal and genital itching. However, it's important to consult with a doctor for any other uses to ensure safety and effectiveness.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions like eczema, seborrheic dermatitis, and psoriasis, as well as for relief from insect bites and reactions to poison ivy, oak, or sumac. It can also help soothe irritation from soaps, detergents, cosmetics, and even jewelry.

In addition to skin irritations, this product can temporarily relieve itching in the external anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before using it.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and water, rinsing thoroughly. After gently drying the area by patting it with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have vaginal discharge or use it for diaper rash; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, seek medical advice if you experience any rectal bleeding.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then come back within a few days. Additionally, if you experience rectal bleeding, stop use and consult your doctor right away. It's important not to start any other hydrocortisone product without first discussing it with your healthcare provider.

Overdose

If you suspect an overdose of this medication, it's important to be cautious, as there is no specific information available about what to expect or how to respond. Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell, it's crucial to seek help immediately.

In the event of an overdose, contact your healthcare provider or local poison control center right away. They can provide guidance on the next steps to take. If you experience severe symptoms, such as difficulty breathing or loss of consciousness, call emergency services for immediate assistance. Always prioritize your health and safety.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this cream is contraindicated (not recommended) for pregnant individuals, nor does it state any known risks to the fetus. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

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 should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children under 12 years of age, you should also seek medical advice.

For adults and children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68-77°F (20 to 25°C). This helps maintain its effectiveness and safety. Always check the carton or tube crimp for the lot number and expiration date, as this information is crucial for confirming the product's validity and safety for use.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of itching associated with minor skin irritations and rashes.

What conditions can this drug help relieve itching from?

It can relieve itching due to eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, soaps, detergents, cosmetics, and jewelry.

Can this drug be used for external anal and genital itching?

Yes, it temporarily relieves external anal and genital itching.

How should adults and children over 2 years use this drug?

Apply to the affected area not more than 3 to 4 times daily.

What should I do if I have vaginal discharge?

Do not use this drug in the genital area if you have vaginal discharge; consult a doctor.

What precautions should I take when using this product?

Avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum.

What should I do if the condition worsens or symptoms persist?

Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is this drug safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this drug during pregnancy mentioned.

How should I store this drug?

Store at 68-77°F (20 to 25°C).

Packaging Info

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

Packaging configurations for Makesense.
Details

Drug Information (PDF)

This file contains official product information for Makesense, 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 specific description details are provided in the text.

Uses and Indications

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

Additionally, this drug provides temporary relief of external anal and genital itching.

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

Dosage and Administration

For the treatment of itching associated with skin irritation and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is recommended before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek medical help without delay.

Healthcare providers should counsel patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if rectal bleeding occurs. Additionally, patients should be advised against initiating the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Emergency medical assistance is crucial if the product is swallowed. Prompt action is necessary to ensure patient safety and appropriate management of potential toxicity.

Side Effects

Patients should be aware that the product is for external use only. In the event of worsening of the condition, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop use and consult a healthcare professional. Additionally, if rectal bleeding occurs, patients should seek medical advice promptly.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Makesense.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is also recommended to seek medical advice prior to application.

For adults and children aged 2 years and older, the product may be applied 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

Hydrocortisone cream is not associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in women of childbearing potential. It is advisable for healthcare providers to monitor pregnant patients closely and to discuss any concerns regarding the use of this medication during pregnancy.

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 lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 context of overdosage, it is important to note that there is no specific information regarding overdosage provided in the available sections of the drug insert.

Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance. In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects and manage symptoms as they arise.

Should an overdose occur, supportive care and symptomatic treatment should be initiated as necessary. It is essential to consult local poison control centers or relevant medical authorities for further guidance on management strategies tailored to the specific circumstances of the overdose.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have vaginal discharge and that they should consult a doctor for the treatment of diaper rash.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be cautioned against using any other hydrocortisone product without first consulting a healthcare professional.

Healthcare providers should also inform patients to stop using the product and seek medical advice if they experience rectal bleeding. While using the product, patients must be reminded to avoid contact with their eyes.

It is essential to communicate to patients that they should not exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 68-77°F (20 to 25°C) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage of the product.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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