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Outgro

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Active ingredient
Benzocaine 18.6 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
October 25, 2024
Active ingredient
Benzocaine 18.6 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
October 25, 2024
Manufacturer
Medtech Products Inc.
Registration number
M017
NDC root
63029-531

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Drug Overview

Outgro is a liquid medication that contains benzocaine, which is used to provide temporary relief from pain associated with minor skin irritations. This product comes in a 0.31 fluid ounce (9 mL) bottle and works by numbing the affected area, helping to alleviate discomfort. If you're dealing with minor skin issues, Outgro may help soothe your pain effectively.

Uses

You can use this medication for the temporary relief of pain caused by minor skin irritations. It is designed to help soothe discomfort and make you feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your minor skin pain.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can use the applicator to apply the medication directly to the affected area. Make sure to do this no more than 3 to 4 times a day for the best results.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for your little one.

What to Avoid

It's important to take care when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should avoid contact with your eyes. This precaution helps ensure your safety and the effectiveness of the treatment. Always follow your healthcare provider's instructions for the best results.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety precautions. You should avoid contact with your eyes, and if your condition worsens or does not improve within 7 days, it's best to stop using the product and consult a doctor. Additionally, if your condition clears up and then returns within a few days, seek medical advice.

This product is for external use only and is extremely flammable, so keep it away from fire or flames and avoid smoking while using it. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please do not apply it to your eyes or ingest it. It is extremely flammable, so keep it away from fire or flames, and avoid smoking while using it and until it has completely dried.

If your condition worsens, does not improve within 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. Additionally, if you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you are unsure. Your safety is the top priority, so don’t hesitate to get the assistance you need.

Pregnancy Use

Currently, there is no information available about the use of Outgro (benzocaine liquid) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product to ensure your safety and the safety of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to note that there is no specific information available about the use of Outgro (benzocaine liquid) during nursing. This means that the effects on breast milk and your nursing infant are not well-studied or documented.

As always, it's a good idea to consult with your healthcare provider before using any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area using an applicator, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, keeping it away from heat sources. This helps maintain its effectiveness and safety.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Outgro used for?

Outgro is used for the temporary relief of pain associated with minor skin irritations.

How should I use Outgro?

For adults and children 2 years of age and older, apply to the affected area using the applicator no more than 3 to 4 times daily. Consult a doctor for children under 2 years of age.

Are there any warnings associated with Outgro?

Yes, Outgro is for external use only and is extremely flammable. Keep it away from fire or flame and avoid smoking during use until the product has dried.

What should I do if my condition worsens while using Outgro?

Stop using Outgro and ask a doctor if your condition worsens, does not improve in 7 days, or clears up and occurs again within a few days.

What should I do if Outgro is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Is there any information about using Outgro during pregnancy or while nursing?

The provided drug insert does not include information regarding the use of Outgro during pregnancy or while nursing.

Are there any contraindications for Outgro?

No contraindications are listed for Outgro.

How should I store Outgro?

Store Outgro at room temperature away from heat.

Packaging Info

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

Packaging configurations for Outgro.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Outgro is a liquid formulation containing benzocaine, a local anesthetic known for its pain-relieving properties. The product is supplied in a volume of 0.31 fluid ounces (9 mL).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor skin irritations.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area using the provided applicator. This application should not exceed 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any of its components. Additionally, contact with the eyes should be strictly avoided due to the potential for irritation or injury.

Warnings and Precautions

For external use only. This product is extremely flammable; therefore, it is imperative to keep it away from fire or flame. Users should avoid smoking during application and until the product has completely dried.

General precautions include the necessity to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is recommended.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, the condition does not improve within 7 days, or if the condition resolves and then recurs within a few days.

In cases of ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is extremely flammable; therefore, it is crucial to keep it away from fire or flame and to avoid smoking during use until the product has completely dried.

While using this product, patients should take care to avoid contact with the eyes. If any adverse reactions occur, such as worsening of the condition, lack of improvement after 7 days, or recurrence of the condition shortly after it has cleared, patients are advised to stop use and consult a healthcare professional.

Additionally, this product should be kept out of the reach of children. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Outgro.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the medication should be applied to the affected area using an applicator, not exceeding 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

There is currently no information available regarding the use of Outgro (benzocaine liquid) during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. Women of childbearing potential should be advised to discuss their pregnancy status and any potential risks with their healthcare provider before using this product.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Outgro (benzocaine liquid). Therefore, the effects on breastfed infants and the excretion of benzocaine in breast milk remain undetermined. Healthcare professionals should exercise caution when considering the use of this product in lactating 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of the reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, does not improve within 7 days, or if the condition clears up and then recurs within a few days.

Additionally, while using the product, patients should be cautioned to avoid contact with their eyes 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, ensuring it is kept away from heat sources to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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