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Dermfree Original Nasal

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This product has been discontinued

Active ingredient
Naphazoline Hcl 0.05 g/100 mL
Other brand names
Dosage form
Spray
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Naphazoline Hcl 0.05 g/100 mL
Other brand names
Dosage form
Spray
Route
Nasal
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 2024
Label revision date
November 20, 2025
Manufacturer
Jiangxi Hemei Pharmaceutical Co. , Ltd
Registration number
M012
NDC root
84010-057
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

This medication is designed to temporarily relieve nasal congestion caused by colds, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, making it easier for you to breathe and feel more comfortable. If you're experiencing these symptoms, this drug may provide the relief you need.

Uses

If you're dealing with nasal congestion from a cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to make you feel more comfortable when you're dealing with these common respiratory issues.

Dosage and Administration

When using this medication, you should apply 2 or 3 sprays in each nostril. This can be done for adults and children aged 6 years and older, but make sure an adult is supervising younger children. You can repeat this process every 10 to 12 hours, but it’s important not to exceed 2 doses within a 24-hour period.

Following these guidelines will help ensure you use the medication safely and effectively. Always remember to keep track of how many doses you’ve taken to avoid going over the recommended limit.

What to Avoid

It's important to be aware of certain precautions when using this medication. First, do not use it in children under 2 years of age. Additionally, make sure to follow the recommended dosage carefully; exceeding it or using the product for more than 3 days can lead to worsening nasal congestion. Always use the medication as directed to avoid potential complications.

Also, keep in mind that sharing this container with others can increase the risk of spreading infections. By following these guidelines, you can help ensure your safety and the effectiveness of the treatment.

Side Effects

If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, it's important to consult your doctor before using this medication. You should also stop using it if your symptoms persist.

For parents, please consult a doctor before giving this medication to children aged 2 to under 6 years.

Warnings and Precautions

Before using this medication, it’s important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may affect how the medication works for you.

If you accidentally swallow the medication, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if your symptoms do not improve, stop taking the medication and reach out to your doctor for further guidance. Your health and safety are the top priority, so don’t hesitate to ask for help when needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Currently, there is no information available about the use of DERMFREE ORIGINAL NASAL (naphazoline hcl 0.05% original nasal spray) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this 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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

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

Pediatric Use

It's important to be cautious when using this medication for children. You should not use it in children under 2 years old. If your child is between 2 and 6 years old, it's best to consult with a doctor before giving them this medication.

For children aged 6 years and older, they can use the medication with adult supervision. The recommended dosage is 2 or 3 sprays in each nostril, but make sure not to use it more often than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. Always prioritize safety and consult a healthcare professional if you have any questions.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it at a temperature that does not exceed 25°C (77°F). Keeping it within this temperature range helps maintain its quality and performance.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use, and dispose of any components according to local regulations to ensure safety and environmental responsibility.

Additional Information

You can use this medication through your nose (nasal administration). For adults and children aged 6 years and older (with adult supervision), the recommended dose is 2 or 3 sprays in each nostril. You should not use it more often than every 10 to 12 hours, and it's important not to exceed 2 doses in a 24-hour period.

FAQ

What does this drug temporarily relieve?

This drug temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

Who can use this drug?

Adults and children 6 years and older can use this drug with adult supervision. It should not be used in children under 2 years.

What is the recommended dosage for adults and children 6 years and older?

The recommended dosage is 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and do not exceed 2 doses in 24 hours.

Are there any warnings before using this drug?

Yes, you should ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

What should I do if symptoms persist?

If symptoms persist, you should stop using the drug and call your doctor.

Is this drug safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of this drug during pregnancy or while nursing.

What should I do if I accidentally swallow this drug?

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

Can this drug be used for more than 3 days?

No, do not use this product for more than 3 days, as frequent or prolonged use may cause nasal congestion to recur or worsen.

Packaging Info

Below are the non-prescription pack sizes of Dermfree Original Nasal (naphazoline hcl 0.05%original nasal). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermfree Original Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is 2 to 3 sprays in each nostril. Administration should not occur more frequently than every 10 to 12 hours. It is important to note that the total number of doses should not exceed 2 doses within a 24-hour period.

Healthcare professionals should ensure that patients are aware of the importance of adhering to these dosing guidelines to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in children under 2 years of age.

Additionally, the product should not be used for more than 3 days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. It is also contraindicated to exceed the recommended dosage.

Caution is advised, as the use of this container by more than one person may facilitate the spread of infection.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is crucial to mitigate potential health risks associated with ingestion.

Patients are advised to discontinue use and contact their healthcare provider if symptoms persist. Ongoing symptoms may indicate a need for reevaluation of the treatment plan or further investigation into underlying health issues.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. Additionally, it is recommended that caregivers consult a doctor before administering this product to children aged 2 to under 6 years.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dermfree Original Nasal (naphazoline hcl 0.05%original nasal). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermfree Original Nasal.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 to under 6 years, it is advised to consult a healthcare professional before use.

In patients 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period. Adult supervision is required for this age group during 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of DERMFREE ORIGINAL NASAL (naphazoline hcl 0.05% original nasal spray) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions, including but not limited to nasal congestion, burning, stinging, sneezing, and increased nasal discharge. Additionally, it has been noted that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product is not recommended for use in children under 2 years of age.

Patients should be instructed to discontinue use if symptoms persist and to adhere strictly to the recommended dosage, as exceeding this may lead to adverse effects. They should also be cautioned against using the product for more than 3 days, emphasizing that it should only be used as directed. Frequent or prolonged use may result in a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or increased nasal discharge. It is crucial to inform patients that sharing this container with others may facilitate the spread of infection. Additionally, healthcare providers should recommend that patients consult a doctor before using the product in children aged 2 to under 6 years.

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 a temperature not exceeding 25°C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 years and older, with adult supervision, the recommended dosage is 2 or 3 sprays in each nostril, not to be taken more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dermfree Original Nasal, 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 Dermfree Original Nasal, 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.