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Neilmed Anti-Itch

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Active ingredient
Hydrocortisone 1 g/1 g
Other brand names
Drug class
Corticosteroid
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 2020
Label revision date
January 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/1 g
Other brand names
Drug class
Corticosteroid
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 2020
Label revision date
January 11, 2024
Manufacturer
NeilMed Pharmaceuticals Inc.
Registration number
M017
NDC root
13709-239
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

NeilMed Anti Itch Spray is a topical solution designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can help alleviate discomfort associated with various conditions, including eczema, poison ivy, oak, and sumac, as well as reactions to cosmetics, soaps, detergents, jewelry, insect bites, and seborrheic dermatitis.

This spray works by targeting the underlying causes of itching, providing you with soothing relief when you need it most. Whether you're dealing with a pesky insect bite or a reaction to a new skincare product, NeilMed Anti Itch Spray can be a helpful option to ease your discomfort.

Uses

You can use this medication to temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, psoriasis, and seborrheic dermatitis, as well as reactions to poison ivy, oak, and sumac. It can also help with irritation from cosmetics, soaps, detergents, jewelry, and insect bites.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects noted with this medication.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years of age, it’s important to consult a doctor before use.

When applying the medication to your face, spray it into the palm of your hand first, then gently apply it to the affected area. This method helps ensure that the medication is applied safely and effectively.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that this product is for external use only and is flammable, so avoid using it while smoking or near heat sources. It’s important not to apply it in or near your eyes, and if accidental exposure occurs, rinse with water or saline immediately and seek medical help if symptoms persist. Use the product only as directed and do not puncture or incinerate the container, as it is under pressure.

If your condition worsens or does not improve within 7 days, or if it clears up and then comes back shortly after, stop using the product and consult your doctor. Additionally, keep it out of reach of children, and if swallowed, seek medical assistance or contact a poison control center right away.

Warnings and Precautions

This product is for external use only and should be kept away from heat, flames, and smoking areas, as it is flammable. Avoid using it near your eyes, and if it accidentally gets in your eyes, rinse immediately with water or saline and seek medical help if symptoms persist. If you are using any other hydrocortisone or corticosteroid products, consult your doctor before using this one. Store it properly, avoiding temperatures above 120°F, and keep it out of reach of children.

If you swallow this product, seek medical help or contact a poison control center right away. You should also stop using it and call your doctor if your condition worsens, does not improve within 7 days, or if it clears up and then comes back shortly after. Always use the product as directed to ensure your safety.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

There is currently no specific information available about the use of NeilMed Anti-Itch Spray during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during this time.

Lactation Use

If you are breastfeeding, you can use NeilMed Anti-Itch Spray without specific warnings or recommendations against it. The information available does not indicate any particular precautions or considerations for nursing mothers regarding this product.

As always, if you have any concerns about using a new product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before using it.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a poison control center immediately. Your child's safety is the top priority, so following these guidelines is essential.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are already taking any other hydrocortisone or corticosteroid products. These medications can interact with each other, potentially affecting how well they work or increasing the risk of side effects.

Always keep your doctor informed about all the medications you are using to ensure your treatment is safe and effective. Your health 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 your product remains safe and effective, store it in a cool, dry place. Avoid temperatures above 104°F (40°C) for long-term storage, and never exceed 120°F (49°C). It's important to keep the product away from heat sources, flames, and smoking areas, as it is flammable.

When handling the product, do not puncture or incinerate it, as the contents are under pressure. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication only on the skin (topically) and apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, consult a doctor before use. Remember, this product is for external use only and is flammable, so avoid using it while smoking or near heat sources.

Be careful not to apply it near your eyes, and if you accidentally get it in your eyes, rinse immediately with water or saline and seek medical help if symptoms persist. Always follow the directions provided, and do not store it in temperatures above 120°F. If your condition worsens or does not improve within 7 days, or if it clears up and then comes back, stop using it and consult a doctor. Keep this product out of reach of children, and if swallowed, seek medical assistance or contact a poison control center right away.

FAQ

What is NeilMed Anti Itch Spray used for?

NeilMed Anti Itch Spray temporarily alleviates itching associated with minor skin irritation, inflammation, and rashes due to conditions like eczema, poison ivy, and insect bites.

How should I use NeilMed Anti Itch Spray?

Shake well before use. Apply to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, it is for external use only and is flammable. Avoid using it near heat or flame, and do not use in or near the eyes.

What should I do if I accidentally swallow NeilMed Anti Itch Spray?

If swallowed, get medical help or contact a poison control center right away.

Can I use NeilMed Anti Itch Spray while pregnant or breastfeeding?

The insert does not provide specific information regarding the use of NeilMed Anti Itch Spray during pregnancy or breastfeeding.

What should I do if my condition worsens or does not improve?

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

Is there any specific information for elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided in the insert.

Packaging Info

Below are the non-prescription pack sizes of Neilmed Anti-Itch (anti-itch spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Neilmed Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NeilMed Anti Itch Spray is a topical formulation designed for the relief of itching. The product is presented in a spray dosage form, facilitating easy application to affected areas. The effective date of this formulation is November 11, 2020. The observation media associated with this product includes an image file, specifically titled "NeilMed Anti-Itch Spray," in JPEG format. The reference value for this product is documented as AIS-12-ENU-US-Rev1-Anti-Itch-20200612-page-001.jpg.

Uses and Indications

This drug is indicated for the temporary alleviation of itching associated with minor skin irritation, inflammation, and rashes due to various conditions, including eczema, poison ivy, oak, and sumac exposure, cosmetics, psoriasis, soaps and detergents, jewelry, insect bites, and seborrheic dermatitis.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The formulation should be shaken well prior to use. For adults and children aged 2 years and older, the product is to be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician before use.

When applying the product to the face, it is recommended to spray the formulation into the palm of the hand and then gently apply it to the desired area.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or open flame. It is contraindicated for use in or near the eyes. In the case of accidental exposure, it is imperative to rinse the affected area with water or saline immediately, remove contact lenses if applicable, and seek medical assistance for any persistent symptoms. The product must be used strictly as directed; puncturing or incinerating the container is prohibited. The contents are under pressure, and long-term storage should be avoided at temperatures exceeding 104°F. Additionally, storage at temperatures above 120°F is not recommended.

Healthcare professionals should advise patients to consult a doctor prior to use if they are currently utilizing any other hydrocortisone or corticosteroid products. Patients should be instructed to discontinue use and seek medical advice if their condition worsens, does not improve within 7 days, or if symptoms resolve only to recur within a few days.

It is essential to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

In summary, patients should be closely monitored for any adverse reactions, and healthcare providers should ensure that patients are aware of the necessary precautions and actions to take in case of accidental exposure or ingestion.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should not be used while smoking or near heat or flame. It is contraindicated for use in or near the eyes, and for diaper rash, a doctor should be consulted. In the event of accidental exposure, it is imperative to rinse the affected area with water or saline immediately, remove contact lenses if applicable, and seek medical assistance for any persistent symptoms.

The product should be used only as directed. Patients are advised against puncturing or incinerating the container, as it is under pressure. Long-term storage above 104°F should be avoided, and it should not be stored at temperatures exceeding 120°F.

Before using this product, patients should consult a doctor if they are currently using any other hydrocortisone or corticosteroid products. If the condition worsens or does not improve within 7 days, or if it clears up and recurs within a few days, patients should discontinue use and seek medical advice.

Additionally, the product should be kept out of reach of children. In the case of ingestion, immediate medical help should be sought or a poison control center contacted.

Drug Interactions

Co-administration of hydrocortisone with other corticosteroid products may lead to an increased risk of systemic corticosteroid effects. It is advisable for patients to consult a healthcare professional prior to using hydrocortisone if they are currently using any other hydrocortisone or corticosteroid products. Monitoring for potential adverse effects associated with corticosteroid use is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Neilmed Anti-Itch (anti-itch spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Neilmed Anti-Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a poison control center.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of NeilMed Anti-Itch Spray during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable for pregnant patients to consult their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of NeilMed Anti-Itch Spray in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or breastfeeding mentioned in the provided text.

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 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

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a poison control center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with the ingestion.

Storage and Handling

The product is supplied in a pressurized container, which must not be punctured or incinerated due to the contents being under pressure. It is essential to handle the product with care, as it is flammable; therefore, it should not be used while smoking or near heat or flame.

For optimal storage, the product should be kept in a cool, dry place. Long-term storage should be avoided at temperatures exceeding 104°F, and it must not be stored at temperatures above 120°F to ensure product integrity and safety.

Additional Clinical Information

The product is administered topically, 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 doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only and is flammable; it should not be used while smoking or near heat or flame. Patients are instructed to avoid contact with the eyes and to seek medical advice for diaper rash. In the event of accidental exposure, immediate rinsing with water or saline is recommended, along with the removal of contact lenses and medical consultation for any persistent symptoms. Patients should use the product only as directed, avoiding puncturing or incinerating the container, and should not store it at temperatures exceeding 120°F. They should consult a doctor if using other hydrocortisone or corticosteroid products, and discontinue use if the condition worsens or does not improve within 7 days. It is crucial to keep the product out of reach of children, and in case of ingestion, medical help or contact with a poison control center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Neilmed Anti-Itch, 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 Neilmed Anti-Itch, 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.