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Flocean Anti-Itch

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Active ingredient
Benzocaine 5 g/100 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2026
Label revision date
February 7, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5 g/100 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2026
Label revision date
February 7, 2026
Manufacturer
Jiangxi Yudexi Pharmaceutical Co. , LTD
Registration number
M017
NDC root
85248-094
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

You may find that this medication is designed to temporarily relieve itching. It works by targeting the discomfort associated with various skin irritations, helping to provide you with some much-needed relief. If you're experiencing itching, this medication could be a helpful option to consider.

Uses

You can use this medication to temporarily relieve itching. It’s designed to help soothe discomfort caused by various skin irritations. If you’re experiencing itching, this product may provide the relief you need. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication.

Dosage and Administration

To use this medication, you should apply a small amount, about the size of your fingertip (approximately a 1-inch strip), directly to the affected area. This can be done up to 3 to 4 times each day. It's important to ensure that the area is clean before application for the best results.

After using the medication, make sure to clean the nozzle of the tube by wiping it thoroughly before putting the cap back on. Always keep the cap tightly closed when you're not using the medication to maintain its effectiveness.

What to Avoid

It’s important to be cautious when using this medication. You should not use it if you have a vaginal discharge; in such cases, please consult your physician for guidance. Additionally, avoid applying the medication over large areas of your body and ensure that it does not come into contact with your eyes, as this could lead to irritation or other issues.

Always prioritize your health and safety by following these instructions closely. If you have any questions or concerns, don’t hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to note that this product is for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, you should consult your doctor. Additionally, if your symptoms improve and then return within a few days, it's advisable to seek medical advice. Avoid applying the product over large areas of your body to minimize potential side effects.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. It's important not to use this product if you have a vaginal discharge; please consult your doctor in that case.

Be careful to avoid contact with your eyes while using this product. If 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.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that the ingredients may be passed into your breast milk, which means you should be cautious when considering its use while nursing. Always prioritize your health and your baby's well-being by discussing any medications or products with your healthcare provider.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can apply a small amount—about the size of a fingertip (approximately a 1-inch strip)—to the affected area. This can be done no more than 3 to 4 times a day. Always follow your healthcare provider's advice to ensure safe and effective use 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 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 your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

You can feel confident knowing that there are no specific storage or handling instructions provided for this product. This means you can use it as intended without worrying about special conditions. Always ensure that you follow any general safety practices when using medical devices, such as keeping your hands clean and using the product in a safe environment. If you have any questions or concerns about its use, don’t hesitate to reach out to your healthcare provider for guidance.

Additional Information

You should apply a fingertip amount (about a 1-inch strip) of the medication to the affected area on your skin. This can be done 3 to 4 times a day for adults and children aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is the primary use of this drug?

This drug temporarily relieves itching.

Who can use this drug?

Adults and children 12 years and older can apply it, while children under 12 should consult a doctor before use.

How should I apply the drug?

Apply a fingertip amount (approximately 1-inch strip) to the affected area not more than 3 to 4 times daily.

Are there any contraindications for using this drug?

Do not use if you have a vaginal discharge; consult a physician if this is the case.

What precautions should I take while using this drug?

Avoid contact with eyes and do not apply over large areas of the body.

What should I do if my condition worsens?

If your condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, consult a physician.

Is this drug safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided; consult a physician.

Can nursing mothers use this drug?

Nursing mothers should consult a physician before using this product due to the potential for excretion in breast milk.

What should I do if I accidentally swallow the drug?

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

Is there any information on drug interactions?

No drug interactions information is provided.

Packaging Info

Below are the non-prescription pack sizes of Flocean Anti-Itch (benzocaine 5%anti-itch). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Flocean Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of itching.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply a fingertip amount, approximately a 1-inch strip, to the affected area. This application should not exceed 3 to 4 times daily.

Prior to each use, it is essential to clean the nozzle of the tube by wiping it thoroughly to prevent contamination. Additionally, the cap should be kept tightly closed between uses to maintain the integrity of the product.

Contraindications

Use is contraindicated in patients with a vaginal discharge; consultation with a physician is advised in such cases.

Additionally, avoid contact with eyes and do not apply the product over large areas of the body to prevent potential adverse effects.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

It is contraindicated to use this product in the presence of vaginal discharge; consultation with a physician is advised in such cases. Healthcare professionals should also instruct patients to avoid contact with the eyes to prevent irritation or injury.

Should the condition worsen, or if symptoms persist beyond 7 days, or if there is a recurrence of symptoms after initial improvement within a few days, the product should not be applied over large areas of the body. In these instances, further evaluation by a healthcare provider is recommended to determine the appropriate course of action.

Side Effects

For external use only. Patients should be advised to seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. It is also important to avoid applying the product over large areas of the body.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Flocean Anti-Itch (benzocaine 5%anti-itch). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Flocean Anti-Itch.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and children aged 12 years and older, the recommended application is a fingertip amount (approximately a 1-inch strip) to the affected area, not exceeding 3 to 4 times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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

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 they should not use the product if they have a vaginal discharge and should consult a physician in such cases.

Patients should be cautioned to avoid contact with their eyes while using the product. Additionally, healthcare providers should instruct patients to discontinue use and consult a healthcare professional 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 also be advised against applying the product over large areas of the body under these circumstances.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

Additional Clinical Information

The medication is administered topically, with a recommended application of a fingertip amount (approximately a 1-inch strip) to the affected area for adults and children aged 12 years and older, not exceeding 3 to 4 times daily. For children under 12 years, it is advised that a clinician be consulted prior to use.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Flocean Anti-Itch, 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 Flocean Anti-Itch, 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.