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Monistat Care Instant Itch Relief

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Active ingredient
Benzocaine 11.4 g/57 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 11.4 g/57 g
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray
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 2017
Label revision date
October 25, 2024
Manufacturer
Insight Pharmaceuticals LLC
Registration number
M017
NDC root
63736-050
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

MONISTAT Care is a topical analgesic spray that contains 20% benzocaine, designed to provide maximum strength and instant relief from pain and itching. This product is particularly useful for soothing discomfort in sensitive areas, offering temporary relief when you need it most.

Uses

You can use this medication for the temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage your symptoms.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those who may be worried about potential risks.

Dosage and Administration

Before using the spray, make sure to shake the can well. Hold it about 8 to 12 inches away from the area you want to treat and spray it generously.

For adults and children aged 12 years and older, you can apply the spray to the affected area up to 3 to 4 times a day. If the person using the spray is under 12 years old, it’s important to consult a physician (doctor) before applying the medication.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. If your condition worsens or if symptoms last longer than 7 days, stop using the medication and consult your doctor. Additionally, if your symptoms improve but then return within a few days, you should also reach out to your healthcare provider. Lastly, be sure to avoid any contact with your eyes while using this product.

Side Effects

When using this product, it's important to be aware of potential side effects and safety warnings. If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. Additionally, avoid contact with your eyes, and if your condition worsens or symptoms persist for more than seven days, stop using the product and consult a doctor.

Keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Remember, this product is for external use only, and misuse can be harmful or even fatal. Always use it as directed and avoid exposing it to heat or flames.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes. If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, do not use this product. Remember that the contents are under pressure and flammable, so keep it away from fire, heat, and temperatures above 120°F (49°C). Misusing the product by inhaling it can be very dangerous.

If your condition worsens or symptoms last longer than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then return within a few days, you should also reach out to your healthcare provider. In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

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 known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If you have a child under 12 years old, it's important to consult a physician before using this medication. For those aged 12 and older, you can apply it to the affected area up to 3 to 4 times a day. Always remember to keep the medication out of reach of children to prevent accidental ingestion. If your child swallows any of the medication, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 you understand how to manage your treatment effectively.

Drug Interactions

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

Additionally, while there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider give you the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15° and 25°C (59° and 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is MONISTAT Care?

MONISTAT Care is a topical analgesic spray containing 20% Benzocaine, designed for maximum strength and instant relief from pain and itching.

How do I use MONISTAT Care?

Shake the can well, hold it 8 to 12 inches from the affected area, and spray liberally. Adults and children 12 years and older can apply it up to 3 to 4 times daily.

Are there any contraindications for MONISTAT Care?

No specific contraindications are listed for MONISTAT Care.

What should I do if I accidentally swallow MONISTAT Care?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

Can I use MONISTAT Care if I have allergies to local anesthetics?

No, you should not use MONISTAT Care if you have a history of allergy to local anesthetics such as procaine, butacaine, or benzocaine.

What precautions should I take when using MONISTAT Care?

Use MONISTAT Care for external use only, avoid contact with the eyes, and do not use it near fire or flame due to its flammable nature.

What should I do if my symptoms persist?

Stop using MONISTAT Care and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is MONISTAT Care safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of MONISTAT Care during pregnancy or lactation.

How should I store MONISTAT Care?

Store MONISTAT Care at room temperature between 15°– 25°C (59°– 77°F).

Packaging Info

Below are the non-prescription pack sizes of Monistat Care Instant Itch Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Monistat Care Instant Itch Relief.
Details

Drug Information (PDF)

This file contains official product information for Monistat Care Instant Itch Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

MONISTAT Care is a topical analgesic formulation containing 20% benzocaine, designed for maximum strength relief of itching. This product is presented in a spray dosage form, providing instant relief from discomfort. The net weight of the product is 2 ounces (57 grams).

Uses and Indications

This drug is indicated for the temporary relief of pain and itching.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should instruct patients to shake the can well before use. The product should be held 8 to 12 inches away from the affected area and sprayed liberally.

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately if the product is swallowed.

Patients should discontinue use and consult a physician if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. It is also important to instruct patients to avoid contact with the eyes.

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.

Contents Under Pressure The product is contained under pressure; therefore, it must not be punctured or incinerated. It is a flammable mixture; hence, 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 imperative 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 Use and Consult a Healthcare Professional Users are advised to discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, it is recommended to stop use and seek medical advice.

Emergency Medical Assistance In the event of accidental ingestion, immediate medical assistance should be sought by contacting 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.

The product is under pressure; therefore, it should not be punctured or incinerated. It is a flammable mixture and should not be used near fire or flame, or exposed to heat or temperatures exceeding 49°C (120°F). Misuse of the product, particularly through intentional concentration and inhalation, can be harmful or even fatal.

While using this product, patients should avoid contact with the eyes. If the condition worsens or symptoms persist for more than 7 days, it is advised to stop use and consult a doctor. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be obtained, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

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 product due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Monistat Care Instant Itch Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Monistat Care Instant Itch Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when prescribing this product to women of childbearing potential and consider the lack of information when evaluating the potential risks and benefits for pregnant patients. It is advisable to monitor any developments in the literature regarding the use of this product in pregnancy and to counsel patients accordingly.

Lactation

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

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 absence of guidance 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

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be instructed to stop using the product and seek medical advice if symptoms resolve but then reoccur within a few days.

It is also important to remind patients to avoid contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 25°C (59° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Monistat Care Instant Itch Relief, 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 Monistat Care Instant Itch Relief, 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.

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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.