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Anesgerm

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This product has been discontinued

Active ingredient
Benzocaine 0.2 g/100 g
Other brand names
Dosage form
Gel
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
May 8, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 0.2 g/100 g
Other brand names
Dosage form
Gel
Route
Oral
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 2015
Label revision date
May 8, 2015
Manufacturer
World Perfumes, Inc
Registration number
part356
NDC root
10095-001
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

GERMA is a maximum strength oral pain reliever designed to provide fast relief from various dental discomforts. It contains 20% benzocaine (a local anesthetic that numbs pain) and oil of cloves, which is known for its soothing properties. You can use GERMA for toothaches, sore gums, teething pain, denture irritation, and braces irritation, making it a helpful option for managing oral pain effectively.

This product is easy to apply, allowing you to target the source of your discomfort quickly and conveniently. Whether you're dealing with a nagging toothache or the irritation from braces, GERMA aims to help you feel more comfortable.

Uses

If you're experiencing discomfort in your mouth, this medication can help with several common issues. It is effective for relieving toothaches, soothing sore gums, and easing the pain associated with teething. If you wear dentures or braces, you may also find this product helpful in reducing irritation caused by these dental appliances.

Rest assured, this medication has not been associated with any teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for managing your oral discomfort.

Dosage and Administration

You can use this medication to help relieve discomfort in both adults and children aged 12 years and older. Simply apply it to the affected area up to four times a day, or follow the specific instructions given by your dentist or doctor.

For teething infants who are at least 4 months old, you can also apply the medication to the affected area up to four times daily, again following any guidance from a healthcare professional. However, if your child is under 2 years old, or if you have an infant younger than 4 months, it’s important to consult a dentist or doctor before using this medication.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help right away. While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your safety is a priority, so please follow these guidelines carefully.

Side Effects

You should be aware of some potential side effects and important warnings associated with this medication. It's crucial not to exceed the recommended dosage and to avoid using it for more than 7 days unless directed by a dentist or doctor. If you have a history of allergies to local anesthetics, such as procaine or benzocaine, you should not use this product.

If your sore mouth symptoms do not improve within 7 days, or if you experience worsening infection, pain, or redness, it's important to stop using the medication and consult a doctor. Additionally, if you notice swelling, a rash, or fever, or if a teething infant over 4 months has a fever and nasal congestion, seek medical advice. These symptoms could indicate an infection or a more serious condition.

Warnings and Precautions

It's important to use this medication safely. Make sure not to exceed the recommended dosage and avoid using it for more than 7 days unless your dentist or doctor advises otherwise. If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product.

You should stop using the medication and contact your doctor if your sore mouth symptoms do not improve after 7 days, or if you experience persistent or worsening infection, pain, or redness. Additionally, seek medical advice if you notice swelling, a rash, or fever, especially in teething infants aged 4 months and older who also have nasal congestion.

If you suspect an overdose, it is crucial to get emergency medical help right away.

Overdose

Taking more medication than recommended can lead to an overdose, which is a serious situation. It’s important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding the recommended dosage can result in harmful effects on your body.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Remember, it’s always better to be safe and consult a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is contraindicated, meaning it should not be used during pregnancy.

Before using any product containing benzocaine, you should consult your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's always best to seek professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare provider before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is experiencing sore gums from teething and is 4 months old or older, you can apply the product to the affected area up to four times a day, or as directed by a dentist or doctor. However, if your child is under 2 years old, it's important to consult with a dentist or doctor before use. For infants younger than 4 months, you should also seek professional advice.

Always supervise children under 12 years of age when using this product. Additionally, if your teething infant shows signs of fever or nasal congestion, these could indicate an infection or a more serious condition, so it's best to consult a healthcare professional.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware of potential interactions when taking medications. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, you should avoid using this medication. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

While there are no specific laboratory test interactions noted, it's always a good practice to inform your healthcare provider about all medications you are taking. This ensures they can provide the safest and most effective care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and keep it protected from light. This helps maintain its quality. It's also important to keep the product out of reach of children to prevent any accidental use. Once you open the product, remember to discard it after use to avoid any potential risks. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, applying it to the affected area up to four times a day. This applies to both adults and children aged 12 years and older, as well as teething infants who are at least 4 months old. Always follow the directions provided by your dentist or doctor for the best results.

FAQ

What is GERMA?

GERMA is a maximum strength oral pain reliever that contains 20% benzocaine and oil of cloves.

What conditions can GERMA be used for?

GERMA is indicated for toothache, sore gums, teething, denture irritation, and braces irritation.

How should I use GERMA?

Apply GERMA to the affected area up to 4 times a day or as directed by a dentist or doctor.

Is GERMA safe for children?

Children under 2 years of age should consult a dentist or doctor before use. Supervision is recommended for children under 12 years.

Can I use GERMA if I am pregnant?

The safety of benzocaine during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if I experience side effects?

Stop using GERMA and consult a doctor if sore mouth symptoms do not improve in 7 days, or if you experience swelling, rash, or fever.

What should I do in case of overdose?

In case of overdose, get medical help immediately.

How should GERMA be stored?

Store GERMA at room temperature, protect it from light, and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Anesgerm.
Details

Drug Information (PDF)

This file contains official product information for Anesgerm, 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 additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the relief of dental discomfort associated with toothache, sore gums, teething, denture irritation, and braces irritation.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the medication to the affected area up to four times a day, or as directed by a dentist or doctor. For teething infants aged 4 months and older, the same application frequency of up to four times daily is recommended, or as directed by a healthcare professional.

For children under 2 years of age, it is essential to consult a dentist or doctor prior to use. Additionally, infants under 4 months of age should also seek guidance from a healthcare professional before application.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought.

Warnings and Precautions

The recommended dosage should not be exceeded, and the product should not be used for more than 7 days unless specifically directed by a dentist or physician. It is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: sore mouth symptoms do not improve within 7 days; there is a persistence or worsening of infection, pain, or redness; or if any swelling, rash, or fever develops. Additionally, in teething infants aged 4 months and older, the presence of fever and nasal congestion warrants immediate consultation with a healthcare provider.

In the event of an overdose, it is critical to obtain emergency medical assistance without delay. Monitoring for these adverse effects is essential to ensure patient safety and effective management of symptoms.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to adhere to the recommended dosage guidelines. Patients are advised not to exceed the recommended dosage and to avoid using the medication for more than 7 days unless directed by a dentist or doctor.

In clinical practice, patients should discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if there is a persistence or worsening of infection, pain, or redness, or if symptoms such as swelling, rash, or fever develop, medical advice should be sought promptly. In teething infants aged 4 months and older, the presence of fever and nasal congestion warrants immediate consultation with a healthcare provider.

It is also important to note that individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this medication. The emergence of any of these symptoms may indicate an underlying infection or a serious condition, necessitating further evaluation by a healthcare professional.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of this medication due to the potential for severe allergic reactions.

No specific interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory tests is not required in relation to this medication.

Packaging & NDC

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

Packaging configurations for Anesgerm.
Details

Pediatric Use

Pediatric patients 4 months of age and older may use this product for sore gums due to teething. The recommended application is up to 4 times daily to the affected area, or as directed by a dentist or doctor.

Children under 12 years of age should be supervised during the use of this product. For infants under 4 months of age, consultation with a dentist or doctor is advised prior to use. Additionally, if fever and nasal congestion are present in teething infants 4 months of age and older, these symptoms may indicate an infection or a serious condition, necessitating medical evaluation.

For children under 2 years of age, it is essential to consult a dentist or doctor before use.

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

The safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

Nursing mothers should consult a healthcare provider before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

Exceeding the recommended dosage of the medication can lead to serious health consequences. Healthcare professionals are advised to strictly adhere to the prescribed dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient for potential symptoms that may arise. These symptoms can vary depending on the specific medication involved and may include a range of physiological and psychological effects.

Management of overdosage should be initiated promptly. Healthcare providers should assess the patient's condition and consider supportive care measures. This may involve monitoring vital signs, providing symptomatic treatment, and, if necessary, implementing specific interventions based on the medication's pharmacological profile.

In cases of severe overdosage, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action. It is essential to document all findings and interventions thoroughly to ensure comprehensive patient care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

Additionally, healthcare providers should instruct patients on the appropriate actions to take in the event of an overdose. Patients must be informed to seek medical help immediately if they suspect an overdose has occurred. This information is vital for ensuring patient safety and prompt medical intervention if necessary.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered orally, with the recommended application frequency being up to four times daily for both adults and children aged 12 years and older, as well as for teething infants aged 4 months and older. Application should be directed to the affected area, following guidance from a dentist or doctor.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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