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Bighero Genital Wart Remover

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Salicylic Acid 17 g/100 g
Other brand names
Dosage form
Ointment
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 21, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 17 g/100 g
Other brand names
Dosage form
Ointment
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 21, 2025
Manufacturer
Jiangxi Hemei Pharmaceutical Co. , Ltd
Registration number
M028
NDC root
84010-047
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 used for the removal of common warts, which are typically rough and have a cauliflower-like appearance. It helps to eliminate these warts, providing relief and improving the appearance of the skin. If you have common warts and are looking for a treatment option, this medication may be suitable for you.

Uses

You can use this medication to help remove common warts, which are typically rough and have a cauliflower-like appearance. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this treatment. This makes it a safer option for those concerned about potential risks during pregnancy.

Dosage and Administration

To start treating your warts, first wash the affected area thoroughly. Soaking it in warm water for about 5 minutes can be helpful. After washing, make sure to dry the area completely.

Next, apply a small amount of the medication directly to each wart, ensuring that it is fully covered. Allow it to dry before putting on any clothing or covering the area. You should repeat this process twice a day as needed, but do not use it for more than 12 weeks. Following these steps will help you manage your warts effectively.

What to Avoid

It's important to use this medication safely. You should not use it on irritated or infected skin, or on any areas that appear reddened. If you have diabetes or poor blood circulation, you should also avoid using this product. Additionally, steer clear of applying it on birthmarks, warts with hair growth, or moles.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, please consult your healthcare provider.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes; if it does happen, rinse your eyes with water for 15 minutes. Additionally, be cautious not to inhale any vapors from the product.

If you experience any discomfort that doesn't go away, you should stop using the product and consult a doctor for further advice. Your health and safety are important, so don't hesitate to seek help if needed.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. If it does get into your eyes, rinse them with water for 15 minutes. It's also important to avoid inhaling any vapors from the product.

If you accidentally swallow the product, seek immediate medical help or contact a Poison Control Center. Additionally, if you experience any discomfort that continues, stop using the product and consult your doctor for further advice.

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 potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on any potential risks and help you make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult a health professional before using this medication. This step ensures that you receive personalized advice regarding any potential effects on your milk production or your nursing infant's health. Always prioritize open communication with your healthcare provider to make informed decisions about your care during this time.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, you should seek immediate medical help or contact a Poison Control Center right away. Taking these precautions can help ensure your child's safety.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided drug insert. This means that if you have renal impairment (kidney issues), you should consult your healthcare provider for personalized advice and guidance regarding your treatment. They can help determine the best approach for your situation, ensuring your safety and the effectiveness of your medication. Always keep your healthcare team informed about your kidney health to receive the most appropriate care.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple steps will help you handle the product safely and effectively.

Additional Information

You should apply a small amount of the medication to cover each wart, allowing it to dry. This should be done twice daily as needed, for a maximum of 12 weeks. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product to ensure it's safe for you.

FAQ

What is this drug used for?

This drug is used for the removal of common warts, which have a rough, cauliflower-like appearance.

How should I apply the drug?

Wash the affected area, dry it thoroughly, and apply a small amount to cover each wart. Let it dry and repeat twice daily as needed, for up to 12 weeks.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes, and if it gets into your eyes, rinse with water for 15 minutes.

What should I do if I experience discomfort?

Stop use and ask a doctor if discomfort persists.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

Where should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use.

What should I do if I swallow this drug?

If swallowed, seek immediate medical help or contact a Poison Control Center.

Who should not use this drug?

Do not use on irritated or infected skin, if you are diabetic or have poor blood circulation, or on birthmarks, warts with hair growth, or moles.

Packaging Info

Below are the non-prescription pack sizes of Bighero Genital Wart Remover (salicylic acid 17%genital wart remover). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bighero Genital Wart Remover.
Details

Drug Information (PDF)

This file contains official product information for Bighero Genital Wart Remover, 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 removal of common warts characterized by a rough, cauliflower-like appearance.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be washed thoroughly, and soaking in warm water for approximately 5 minutes may facilitate this process. After cleansing, the area must be dried completely. A small amount of the medication should then be applied to cover each wart, ensuring that it is allowed to dry. This application should be repeated twice daily as necessary, with treatment continuing for a maximum duration of 12 weeks.

Contraindications

Use is contraindicated in the following situations:

Application on irritated or infected skin, or on areas exhibiting redness, is not recommended due to the potential for exacerbating the condition.

Patients with diabetes or poor blood circulation should avoid use, as these conditions may increase the risk of adverse effects.

Additionally, the product should not be applied to birthmarks, warts with hair growth, or moles, as these may present unique risks during treatment.

Warnings and Precautions

The product is intended for external use only. It is imperative to avoid contact with the eyes. In the event that the product comes into contact with the eyes, it is essential to rinse thoroughly with water for a minimum of 15 minutes. Additionally, users should take care to avoid inhaling vapors associated with the product.

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

If discomfort persists after use, it is advised to discontinue use of the product and consult a healthcare professional for further evaluation and guidance.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept away from the eyes. In the event that the product comes into contact with the eyes, it is recommended to rinse thoroughly with water for at least 15 minutes. Additionally, patients should avoid inhaling vapors associated with the product.

If any discomfort persists after using the product, patients are advised to discontinue use and 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 necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Bighero Genital Wart Remover (salicylic acid 17%genital wart remover). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bighero Genital Wart Remover.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

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

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to irritated or infected skin, or to areas that are reddened.

Patients with diabetes or poor blood circulation should be cautioned against using the product on birthmarks, warts with hair growth, or moles. Healthcare providers should encourage patients to stop using the product and consult a doctor if discomfort persists after application.

Additionally, it is essential for healthcare providers to recommend that patients who are pregnant or breastfeeding consult a health professional before using the product to ensure safety for both the patient and the child.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to cover each wart. Patients should allow the application to dry and may repeat this process twice daily as needed, for a maximum duration of 12 weeks.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional 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 Bighero Genital Wart Remover, 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 Bighero Genital Wart Remover, 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.