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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
84010-058
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 also works to ease sinus congestion and pressure, making it easier for you to breathe comfortably.

You can rely on this treatment to help alleviate those bothersome symptoms, allowing you to feel more at ease during your recovery.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If it’s your first time using it, remove the protective cap and clip from the tip. You’ll need to prime the metered pump by pressing it down firmly several times until you see a fine mist.

For adults and children aged 6 years and older, you can use 2 or 3 sprays in each nostril. Just remember not to use it more often than every 10 to 12 hours, and don’t exceed 2 doses in a 24-hour period. If you have a child between 2 and 6 years old, consult a doctor before use. This medication is not suitable for children under 2 years. After using the spray, be sure to wipe the nozzle clean to keep it in good condition.

What to Avoid

It's important to use this product carefully to avoid potential issues. You should not use it for more than 3 days, as frequent or prolonged use can lead to worsening nasal congestion. Always follow the directions provided and do not exceed the recommended dosage. Be aware that temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge, may occur.

Additionally, this product should not be used in children under 2 years old, and sharing the container with others can increase the risk of spreading infections. Please prioritize your health and safety by adhering to these guidelines.

Side Effects

If you are considering using this product, it's important to be aware of potential side effects. Some people may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, using this product for more than three days or exceeding the recommended dosage can lead to worsening nasal congestion.

You should not use this product if you are allergic to any of its ingredients. It's also advisable to consult a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. If your symptoms persist, please stop using the product and seek medical advice.

Warnings and Precautions

You should not use this product if you are allergic to any of its ingredients. Before using it, 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. While using this product, make sure to follow the recommended dosage and do not use it for more than three days. Overuse can lead to worsening nasal congestion. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections.

If your symptoms do not improve, stop using the product and contact your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

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

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this product unless your doctor specifically advises you to do so. The safety of naphazoline during pregnancy has not been established, and there may be potential risks to your developing baby. It’s essential to discuss these risks with your healthcare provider to understand the implications for your situation.

If you do need to use this product while pregnant, consult your doctor for guidance on the appropriate dosage. Always approach the use of any medication during pregnancy with caution, weighing the potential benefits against the possible risks to your fetus.

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. This means that, based on the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its safety during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 using it.

For children aged 6 years and older, you can administer 2 or 3 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours. Additionally, do not exceed 2 doses within a 24-hour period. Always ensure that an adult supervises the use in older children.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 best performance and safety of your product, store it in a cool, dry place where the temperature does not exceed 25°C (77°F). Keeping the product within this temperature range helps maintain its effectiveness.

It's also important to keep the original box, as it contains valuable information and labeling that you may need for future reference. Proper handling and storage will help you use the product safely and effectively.

Additional Information

You should use this medication by spraying it into your nostrils. For adults and children aged 6 years and older (with adult supervision), the recommended dose is 2 or 3 sprays in each nostril, but you should not use it more than once every 10 to 12 hours. Make sure not to exceed 2 doses in a 24-hour period to ensure safe use.

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. For children aged 2 to under 6 years, consult a doctor.

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 for using this drug?

Yes, do not use if you are allergic to the ingredients, and consult a doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Can this drug be used during pregnancy?

Do not use this product if you are pregnant or planning to become pregnant unless directed by a doctor, as the safety of naphazoline during pregnancy has not been established.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist.

What are the potential side effects of this drug?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur.

How should I use this drug?

Shake well before use, remove the protective cap, prime the pump, and spray while sniffing deeply. Wipe the nozzle clean after use.

What should I do if I accidentally swallow this drug?

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

Is there any specific information for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

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

Adults and children aged 6 years and older, under adult supervision, are advised to administer 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and the total number of doses should not exceed 2 in a 24-hour period.

For children aged 2 to under 6 years, consultation with a healthcare professional is recommended prior to use. The product is contraindicated in children under 2 years of age.

Prior to the initial use, the bottle must be shaken well. The protective cap should be removed, and any clips from the tip should be safely discarded. The metered pump should be primed by firmly depressing it several times.

For administration, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The pump must be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle should be wiped clean to maintain hygiene.

Contraindications

Use of this product is contraindicated in the following situations:

  • 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.

  • Temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge, may occur; however, this does not constitute a reason for use.

  • The product should not be shared among multiple users to prevent the risk of infection transmission.

  • It is contraindicated in children under 2 years of age due to safety concerns.

  • Exceeding the recommended dosage is contraindicated to avoid potential adverse effects.

Warnings and Precautions

Patients should not use this product if they have a known allergy to any of its ingredients. Prior to use, it is essential for individuals with a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland to consult a healthcare professional.

During the use of this product, it is critical to adhere to the recommended dosage and duration of use. Users should not exceed the recommended dosage and should limit use to no more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product among multiple users may pose a risk of spreading infection.

Patients are advised to discontinue use and consult a healthcare provider if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur in individuals who are allergic to any of the ingredients. It is advised that patients 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.

Common adverse reactions reported during use include temporary discomfort, which may manifest as burning, stinging, sneezing, or increased nasal discharge. These reactions are generally mild and transient. Patients are cautioned against exceeding the recommended dosage and should not use the product for more than three days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

In the event that symptoms persist, patients are advised to discontinue use and consult a doctor. Additionally, it is important to note that the use of this product by more than one person may increase the risk of spreading infection.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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. The total dosage should not exceed 2 doses within a 24-hour period. Adult supervision is required for this age group.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

The use of this product is not recommended for pregnant patients or those planning to become pregnant unless specifically directed by a healthcare provider. The safety of naphazoline during pregnancy has not been established, and potential risks to the fetus should be thoroughly discussed with a healthcare professional.

Healthcare providers should consider the potential benefits of treatment against the possible risks to fetal outcomes. If a pregnant patient requires this medication, dosage modifications may be necessary, and it is essential to consult a doctor for appropriate dosing. Special precautions should be taken, and the use of this product during pregnancy should only occur if the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or its effects on breastfed infants.

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 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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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

Postmarketing experience has revealed reports of adverse reactions, including but not limited to nasal congestion, burning, stinging, sneezing, and increased nasal discharge. Additionally, there have been instances of infection spread associated with the use of this container by more than one person.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that this product should not be used for more than three days and must be used only as directed. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or increased nasal discharge. Healthcare providers should emphasize that the use of this container by more than one person may increase the risk of spreading infection.

Patients should be instructed to stop using the product and consult a doctor if their symptoms persist. Additionally, it is crucial to remind patients not to exceed the recommended dosage to avoid potential adverse effects.

Storage and Handling

The product is supplied in packaging that includes relevant NDC numbers. It is essential to store the product at a temperature not exceeding 25°C to maintain its integrity and efficacy. Healthcare professionals are advised to retain the original box for future reference regarding the complete labeling information. Special handling considerations should be observed to ensure optimal storage conditions are maintained.

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, and should not exceed 2 doses within a 24-hour period.

There is no additional information 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.

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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.