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Flocean Anti-Itch

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This product has been discontinued

Active ingredient
Benzocaine 5 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 2024
Label revision date
November 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5 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 2024
Label revision date
November 20, 2025
Manufacturer
Jiangxi Hemei Pharmaceutical Co. , Ltd
Registration number
M017
NDC root
84010-017
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 effectively, 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.

After each use, make sure to clean the nozzle of the tube by wiping it thoroughly before putting the cap back on. It's also important to keep the cap tightly closed when you're not using the medication to ensure it stays effective.

What to Avoid

You should not use this product if you have a vaginal discharge; it's important to consult a physician in that case. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, stop using the product. Additionally, avoid applying it over large areas of your body.

While using this product, be careful to avoid contact with your eyes, as this can lead to irritation or other issues. Always prioritize your health and safety by following these guidelines.

Side Effects

For your safety, this product is intended for external use only. If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product. It's also important not to apply it over large areas of your body. If you have any concerns or questions, please consult your doctor.

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.

You should stop using the product if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, avoid applying it over large areas of your body and keep it away from your eyes.

Overdose

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

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

When considering the use of FLOCEAN ANTI-ITCH (benzocaine 5% anti-itch cream) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter products like this cream. They can help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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 fingertip amount (about a 1-inch strip) 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 safe and effective use for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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

It appears that there are no specific storage or handling instructions provided for the product or device. This means you can generally assume that it should be kept in a cool, dry place, away from direct sunlight and extreme temperatures.

For safety, always handle the product with clean hands and ensure that any surfaces or tools you use are clean as well. If you have any concerns or questions about the product's storage or handling, it's best to consult with a healthcare professional or refer to the manufacturer's guidelines.

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 are no additional details 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.

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

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

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

Stop use if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and occur again within a few days.

Can I use this drug if I have a vaginal discharge?

No, you should not use this drug if you have a vaginal discharge and should consult a physician.

Is this drug safe for children under 12 years?

Consult a doctor before use for children under 12 years.

What should I do if I accidentally swallow this drug?

Get medical help or contact a Poison Control Center right away.

Is this drug for external use only?

Yes, this drug is for external use only.

What precautions should I take when using this drug?

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

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

Discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and recur within a few days. Application over large areas of the body is not recommended.

During use, avoid contact with the eyes.

Warnings and Precautions

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

The product is contraindicated in individuals with vaginal discharge; consultation with a physician is advised prior to use in such cases.

Users should discontinue use 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 also important to avoid applying the product over large areas of the body.

Care should be taken to prevent contact with the eyes, as this may lead to irritation or other adverse effects.

Side Effects

For external use only. Patients are advised to discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also recommended that the product not be applied over large areas of the body.

In the event of any of the aforementioned conditions, patients should consult a healthcare professional for further guidance.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 dosage is a fingertip amount (approximately a 1-inch strip) applied 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of FLOCEAN ANTI-ITCH (benzocaine 5% anti-itch cream) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant individuals, as the potential risks and effects on fetal outcomes are not well characterized. It is advisable to weigh the benefits against any unknown risks when recommending this treatment to women of childbearing potential.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. Further monitoring of breastfed infants may be warranted, although no adverse effects have been documented in the available data.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document the incident thoroughly, including the substance involved, estimated dose, time of exposure, and any interventions performed. This information is vital for ongoing patient care and for any necessary reporting to regulatory authorities.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to respond effectively to potential overdose situations, ensuring prompt assessment and management to mitigate risks to patient health.

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 fully evaluate the nonclinical toxicology profile.

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 instructed to discontinue use 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, they should be cautioned against applying the product over large areas of the body.

While using the product, patients must be reminded 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. However, there are no specified storage or handling instructions provided in the SPL text. It is recommended that healthcare professionals refer to standard storage practices for similar products and ensure that the product is stored in a suitable environment to maintain its integrity.

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. Clinicians should advise that children under 12 years consult a doctor prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.