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Bloop Itch Soothing Topical

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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
November 30, 2023
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
November 30, 2023
Manufacturer
Three Nations Corp
Registration number
M017
NDC root
83838-415
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 temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema (a skin condition that causes inflammation and irritation), insect bites, seborrheic dermatitis (a skin disorder that causes scaly patches and red skin), and psoriasis (a chronic skin condition that leads to the rapid growth of skin cells).

Additionally, it can provide temporary relief from itching in external genital, feminine, and anal areas. For any other uses, it is important to consult with a doctor for proper guidance and supervision.

Uses

You can use this product to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, seborrheic dermatitis, and psoriasis. If you're experiencing itching in sensitive areas, such as the external genital area, feminine regions, or around the anus, this product can also help provide temporary relief.

It's important to note that any other uses of this product should only be done under the guidance and supervision of a doctor. Always consult with a healthcare professional if you have questions or concerns about your symptoms.

Dosage and Administration

If you're dealing with itching, skin irritation, inflammation, or rashes, you can apply the medication directly to the affected area. For adults and children aged 12 and older, use it 3 to 4 times a day until your symptoms improve, but don’t use it for more than two weeks.

If you're experiencing external anal or genital itching, start by gently drying the area with toilet tissue or a soft cloth. You can then apply the product to the skin around the anal canal using a clean finger. Just like before, use it no more than 3 to 4 times daily. If the person needing treatment is under 12 years old, it's best to consult a doctor before use.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care to follow safety guidelines.

If you accidentally swallow the medication, seek medical help or contact a Poison Control Center right away. Your safety is a priority, so please ensure you adhere to this instruction.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if your condition worsens, does not improve within 7 days, or if you experience bleeding that lasts beyond 7 days. Additionally, avoid using this product in the genital area if you have genital itch associated with penile or vaginal discharge.

Remember to keep the product away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. It's also crucial not to insert this product into the rectum using fingers or any devices. This product is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have any itching associated with penile or vaginal discharge. While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless your doctor advises you to do so. It's important not to insert this product into the rectum using your fingers or any device.

If your condition worsens, does not improve within 7 days, or if you experience bleeding that lasts beyond 7 days, stop using the product and consult your doctor. Additionally, if you accidentally swallow the product, seek medical help or contact a Poison Control Center right away.

Overdose

Taking more medication than recommended can lead to serious health issues. It’s important to follow the dosage instructions provided by your doctor or on the medication label. If you accidentally take too much, you may experience symptoms that could indicate an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you suspect an overdose, seek immediate medical help or contact your local poison control center. Always prioritize your safety by sticking to the recommended dosage unless your doctor advises otherwise.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

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 associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their health.

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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It's important to keep it away from light to maintain its effectiveness. When you're not using the product, make sure the tube is tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication to the affected area 3 to 4 times daily until your symptoms improve, but not for more than two weeks. If you're treating external anal and genital itching, limit application to 3 to 4 times daily. Remember, this product is for external use only, and you should avoid using it in the genital area if you have any discharge.

Be careful to keep the medication away from your eyes and do not exceed the recommended dosage unless your doctor advises you to do so. Never insert this product into the rectum using fingers or any device. If your condition worsens, does not improve within 7 days, or if you experience bleeding that lasts beyond 7 days, stop using the product and consult a doctor. If you accidentally swallow the medication, seek medical help or contact a Poison Control Center right away. Always consult a healthcare professional before use if you have any questions.

FAQ

What conditions does this product temporarily relieve?

This product temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, seborrheic dermatitis, and psoriasis.

Can this product be used for external genital or anal itching?

Yes, it temporarily relieves external genital, feminine, and anal itching.

What should I do if I have genital itch associated with discharge?

Do not use this product in the genital area if you have genital itch associated with penile or vaginal discharge.

How should adults and children 12 years and older use this product?

Apply to the affected area 3 to 4 times daily until symptoms resolve or for a maximum of two weeks.

What should I do if I swallow this product?

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

What precautions should I take when using this product?

Avoid contact with eyes, do not exceed the recommended dosage unless directed by a doctor, and do not put this product into the rectum using fingers or any device.

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

Stop use and ask a doctor if your condition worsens or does not improve within 7 days, or if bleeding persists beyond 7 days.

Is there any specific information for children under 12 years of age?

Children under 12 years of age should consult a doctor before use.

How should I store this product?

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

Packaging Info

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

Packaging configurations for Bloop Itch Soothing Topical.
Details

Drug Information (PDF)

This file contains official product information for Bloop Itch Soothing Topical, 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, inflammation, and rashes due to conditions such as eczema, insect bites, seborrheic dermatitis, and psoriasis.

Additionally, it provides temporary relief for external genital, feminine, and anal itching.

Limitations of use: Other applications of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For the treatment of itching, skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 12 years and older is to apply the product to the affected area 3 to 4 times daily. This application should continue until symptoms resolve or for a maximum duration of two weeks.

In cases of external anal and genital itching in adults, it is advised to gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to application. The product may be applied to the skin of the anal canal using a clean finger. The application should not exceed 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is recommended before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for use in the genital area, particularly in cases where there is genital itch associated with penile or vaginal discharge.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage; exceeding this dosage should only occur under the guidance of a healthcare professional. Additionally, this product must not be administered rectally using fingers, mechanical devices, or applicators.

Patients should discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, there is no improvement within 7 days, or if bleeding persists beyond 7 days. It is advised not to initiate the use of any other hydrocortisone product during this time.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in the genital area if there is genital itch associated with penile or vaginal discharge.

During the use of this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended dosage. Exceeding the recommended dosage should only occur under the guidance of a healthcare professional. Additionally, patients should not insert this product into the rectum using fingers, mechanical devices, or applicators.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if there is no improvement within 7 days, or if bleeding persists beyond 7 days. It is also advised not to initiate the use of any other hydrocortisone product without medical consultation.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Bloop Itch Soothing Topical (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bloop Itch Soothing Topical.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

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

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 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 cases of overdosage, it is imperative that healthcare professionals adhere to the recommended dosage guidelines unless otherwise directed by a physician. Exceeding the recommended dosage can lead to adverse effects and complications that may require immediate medical attention.

Healthcare providers should be vigilant for potential symptoms associated with overdosage, which may vary depending on the specific medication involved. It is essential to monitor patients closely for any signs of toxicity or adverse reactions.

In the event of suspected overdosage, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's condition, including a review of the medication taken, the amount ingested, and the time of ingestion.

  2. Supportive Care: Provide supportive care as necessary, which may include monitoring vital signs and administering symptomatic treatment.

  3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the substance involved.

  4. Emergency Intervention: Be prepared to initiate emergency interventions if the patient exhibits severe symptoms or complications resulting from the overdosage.

Prompt recognition and appropriate management of overdosage are crucial in mitigating potential risks and ensuring patient safety.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This information is vital for ensuring patient safety and prompt intervention if necessary.

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) and must be protected from light exposure. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area 3 to 4 times daily until symptoms resolve, with a maximum duration of two weeks. For adults experiencing external anal and genital itching, application should not exceed 3 to 4 times daily.

Clinicians should counsel patients that the product is for external use only and should not be applied to the genital area if there is associated penile or vaginal discharge. Patients must avoid contact with the eyes and should not exceed the recommended dosage unless directed by a healthcare professional. It is important to instruct patients not to insert the product into the rectum using fingers or any mechanical device. They should discontinue use and consult a doctor if the condition worsens, does not improve within 7 days, or if bleeding persists beyond 7 days. Patients should seek medical help or contact a Poison Control Center immediately if the product is swallowed.

Drug Information (PDF)

This file contains official product information for Bloop Itch Soothing Topical, 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 Bloop Itch Soothing Topical, 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

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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.