Americaine

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor cuts, scrapes, minor burns, and insect bites.

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

Dosage and Administration

The can should be shaken well before use. The product is to be held 6 to 12 inches away from the affected area and sprayed liberally.

For adults and children aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, due to the risk of severe allergic reactions.

Additionally, the product should not be punctured or incinerated, as this may lead to hazardous situations. It is also contraindicated to use this product near fire or flame, or to expose it to heat or temperatures exceeding 49°C (120°F), as this poses a risk of combustion or explosion.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics.

Flammability Warning The contents of this product are under pressure and are flammable. It is imperative to avoid puncturing or incinerating the container. The product should not be used near fire or flame, nor should it be exposed to heat or temperatures exceeding 49°C (120°F). It is essential to use this product only as directed. Intentional misuse, such as deliberately concentrating and inhaling the contents, can result in serious harm or be fatal.

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

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if there is an increase in redness, irritation, swelling, pain, or other symptoms.

Get Emergency Medical Help Instructions In the event of accidental ingestion, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only. Individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product due to the risk of allergic reactions.

There is a significant flammability warning associated with this product. The contents are under pressure, and it is crucial to avoid puncturing or incinerating the container. The product is a flammable mixture; therefore, it should not be used near fire or flame, nor should it be exposed to heat or temperatures exceeding 49°C (120°F). It is essential to use the product only as directed, as intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

While using this product, patients should take care to avoid contact with the eyes. If the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms do not improve or if redness, irritation, swelling, pain, or other symptoms occur or increase, medical advice should be sought promptly.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 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. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of available data, it is advisable to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individualized assessment and consideration of the patient's overall health status, comorbidities, and concurrent medications are recommended to ensure safe and effective use in this population.

Pregnancy

The safety of Americaine (benzocaine) during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician prior to use. There may be potential risks associated with the use of benzocaine during pregnancy; however, specific studies or data regarding fetal outcomes are not provided in the prescribing information.

While no specific dosage modifications for pregnant individuals are mentioned, caution is advised. It is recommended that this product be used only if clearly needed, and the risks and benefits should be discussed with a healthcare provider to ensure informed decision-making.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, careful consideration and professional guidance are recommended for nursing mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

Postmarketing experience has indicated that benzocaine can lead to methemoglobinemia, a serious condition characterized by a reduced capacity of the blood to carry oxygen. Cases of methemoglobinemia have been documented in patients utilizing benzocaine products, with a notable prevalence in infants and young children. Additionally, adverse reactions reported in the postmarketing experience encompass allergic reactions, skin irritation, and various hypersensitivity reactions.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients not to use this product if they have a known allergy to local anesthetics, including procaine, butacaine, benzocaine, or any other “caine” anesthetics.

Providers should emphasize the flammability warning associated with this product. Patients should be cautioned that the contents are under pressure and that they must not puncture or incinerate the container. Additionally, patients should be advised to avoid using the product near fire or flame and to refrain from exposing it to heat or temperatures exceeding 49°C (120°F). Patients should use the product only as directed, and they should be made aware that intentional misuse by concentrating and inhaling the contents can be harmful or fatal.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms do not improve or if they experience increased redness, irritation, swelling, pain, or any other concerning symptoms.

Finally, healthcare providers should remind patients to avoid contact with the eyes while using this product.

Storage and Handling

The product is supplied in a configuration that includes contents under pressure. It is essential to store the product at room temperature, specifically within the range of 15° to 25°C (59° to 77°F).

Due to the flammable nature of the mixture, it is critical to avoid using the product near fire or flame, and to prevent exposure to heat or temperatures exceeding 49°C (120°F). Additionally, the container must not be punctured or incinerated to ensure safety and integrity of the product.

Additional Clinical Information

Patients should be advised that the product is for topical administration, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a physician is necessary. Clinicians should counsel patients to avoid contact with the eyes and to discontinue use if the condition worsens or if symptoms persist beyond 7 days. Additionally, patients should seek medical attention if symptoms such as redness, irritation, swelling, or pain occur or worsen.

It is important to inform patients about the potential risks associated with intentional misuse, particularly the dangers of deliberately concentrating and inhaling the product, which can be harmful or fatal. Patients should also be reminded to keep the product out of reach of children and to seek immediate medical help or contact a Poison Control Center if ingested.

Drug Information (PDF)

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

View product document (PDF)