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Topical Anesthetic

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
December 17, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
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 2012
Label revision date
December 17, 2017
Manufacturer
Safco Dental Supply Co.
Registration number
part356
NDC root
67239-0206
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

SAFCO SensiCaine is a topical anesthetic gel designed to numb specific areas of the skin. It contains 20% benzocaine, which is a medication that works by blocking nerve signals in your body, providing relief from pain or discomfort. This gel is typically used in professional settings, ensuring that it is applied safely and effectively by trained individuals.

With its bubble gum flavor, SAFCO SensiCaine is formulated to make the experience more pleasant. However, it's important to note that this product is available only through a prescription, reflecting its intended use in controlled environments.

Uses

This medication is a topical anesthetic gel designed for professional use only. It is applied to the skin to help numb the area, making procedures more comfortable for you.

There are no specific teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with this gel. Always consult with a healthcare professional for more information on its use and safety.

Dosage and Administration

You should use this medication only in your mouth, as directed by your dentist. It's important to follow their instructions carefully to ensure you get the best results. If you have any questions about how to use it or when to apply it, don't hesitate to ask your dentist for clarification.

What to Avoid

It’s important to be aware of certain precautions when using this medication. You should not use it if you have known allergies to benzocaine or PABA compounds, as this could lead to serious reactions. Additionally, to ensure safety, always keep this medication out of reach of children.

Be mindful that this medication may have potential for abuse or misuse, and it is classified as a controlled substance. This means it should be used only as directed by your healthcare provider to avoid issues related to dependence (a condition where your body becomes reliant on a substance).

Side Effects

It's important to be aware of potential side effects when using this medication. If you have a known allergy to benzocaine or PABA compounds, you should avoid using this product, as it may cause serious allergic reactions.

While specific side effects are not detailed here, always consult with your healthcare provider if you experience any unusual symptoms or reactions after using the medication. Your safety is a priority, so staying informed is key.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have a known allergy to benzocaine or PABA compounds, you should not use this product, as it could trigger a serious allergic reaction.

If you experience any unusual symptoms or reactions, stop using the medication immediately and contact your doctor for further guidance. Always prioritize your safety and well-being when using any medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach any medication with caution during pregnancy. Since there are no special precautions mentioned, it is advisable to consult with your healthcare provider before taking any medication if you are pregnant or planning to become pregnant. They can provide personalized guidance based on your health needs and circumstances.

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 are no statements about the product being excreted in breast milk or any associated risks for your infant. This means that, based on current information, you can use this product without concern for its effects on your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child has a known allergy to benzocaine or PABA compounds, you should avoid using this product, as it could cause an allergic reaction. Always consult with a healthcare professional if you have any concerns about its use in children.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always discuss any new medications, supplements, or changes in your health with your provider. They can help you understand how different treatments may work together and monitor your health effectively. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 59-86°F (15-30°C). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is SAFCO SensiCaine?

SAFCO SensiCaine is a topical anesthetic gel that contains 20% benzocaine and is intended for professional use only.

What flavor does SAFCO SensiCaine have?

SAFCO SensiCaine has a bubble gum flavor.

What is the packaging size of SAFCO SensiCaine?

SAFCO SensiCaine is packaged in a 1 oz. (34 g) container.

Is a prescription required for SAFCO SensiCaine?

Yes, federal law prohibits dispensing SAFCO SensiCaine without a prescription.

Who should not use SAFCO SensiCaine?

You should not use SAFCO SensiCaine if you have known allergies to benzocaine or PABA compounds.

What precautions should be taken when using SAFCO SensiCaine?

Keep SAFCO SensiCaine out of reach of children and do not use it on individuals with known allergies to benzocaine or PABA.

Can SAFCO SensiCaine be used during pregnancy?

The provided information does not specify any precautions or recommendations for using SAFCO SensiCaine during pregnancy.

Is SAFCO SensiCaine safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of SAFCO SensiCaine in nursing mothers.

What is the route of administration for SAFCO SensiCaine?

SAFCO SensiCaine is administered via the dental route.

What is the recommended storage temperature for SAFCO SensiCaine?

Store SAFCO SensiCaine at a controlled room temperature of 59-86°F (15-30°C).

Packaging Info

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

Packaging configurations for Topical Anesthetic.
Details

Drug Information (PDF)

This file contains official product information for Topical Anesthetic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

SAFCO SensiCaine is a topical anesthetic gel formulated for professional use only. It contains 20% benzocaine as the active ingredient, providing effective local anesthesia. The gel is presented in a 1 oz. (34 g) container and features a bubble gum flavor, enhancing patient acceptability during application.

Uses and Indications

This drug is indicated as a topical anesthetic gel for professional use only. It is intended for application by healthcare professionals in appropriate clinical settings.

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

Dosage and Administration

The product is intended for oral mucosal use only, and it should be administered strictly as directed by a qualified dentist. Healthcare professionals are advised to ensure that patients understand the importance of adhering to the prescribed usage guidelines to achieve optimal therapeutic outcomes.

Contraindications

Use is contraindicated in individuals with known allergies to benzocaine and PABA compounds due to the risk of severe allergic reactions. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Caution is advised when considering the use of this product in individuals with known allergies to benzocaine and para-aminobenzoic acid (PABA) compounds. The potential for allergic reactions necessitates careful screening of patient history prior to administration.

Healthcare professionals are encouraged to monitor patients for any signs of adverse reactions, particularly in those with a history of sensitivities to similar compounds.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals with known allergies to benzocaine and PABA compounds.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported beyond the contraindications. However, healthcare providers should remain vigilant for any signs of allergic reactions in patients with a history of sensitivity to these compounds. It is essential to monitor patients for any unexpected reactions following administration, particularly in those with a known allergy history.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Topical Anesthetic.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The use of this product is contraindicated in individuals with known allergies to benzocaine and PABA compounds. Caution is advised when considering the use of this medication in pediatric populations, and healthcare professionals should assess the risk of allergic reactions prior to administration.

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 may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 keep the medication out of reach of children to prevent accidental ingestion or misuse. It is essential to inform patients that the product should not be used by individuals with known allergies to benzocaine or PABA compounds, as this may lead to serious allergic reactions. Providers should encourage patients to read the label carefully and discuss any concerns or questions regarding their allergies or the use of this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature, maintained between 59°F to 86°F (15°C to 30°C). Proper storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is dental. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Topical Anesthetic, 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 Topical Anesthetic, 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.