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Dermfree Original Nasal

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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 2026
Label revision date
February 8, 2026
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 2026
Label revision date
February 8, 2026
Manufacturer
Jiangxi Yudexi Pharmaceutical Co. , LTD
Registration number
M012
NDC root
85248-112
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. In addition to easing nasal congestion, it also helps alleviate sinus congestion and pressure, making it easier for you to breathe and feel more comfortable.

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 uncomfortable symptoms. It's designed to make you feel more comfortable when you're dealing with these common respiratory issues.

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 pump by pressing it down firmly several times until you see a spray.

For adults and children aged 12 and older (with adult supervision), 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’re considering this medication for children aged 6 to under 12 years, it’s best to consult a doctor first. This medication is not recommended for children under 6 years old.

When you’re ready to spray, hold the bottle with your thumb at the base and your fingers on either side of the nozzle. Keep your head upright and insert the nozzle into your nostril. Press the pump down firmly and sniff deeply at the same time. After using, make sure to wipe the nozzle clean to keep it in good condition.

What to Avoid

You should avoid using this product if you are allergic to any of its ingredients or if you do not have nasal congestion. It is also important not to use it in children under 6 years of age. Additionally, be cautious with the frequency and duration of use, as using it too often can lead to a worsening of nasal congestion. Always follow the recommended dosage and do not exceed it to ensure your safety.

Side Effects

You should avoid using this medication if you are allergic to any of its ingredients. It's important to consult with your doctor before using it 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.

If you experience persistent symptoms, stop using the medication and seek medical advice. Additionally, if you are pregnant or breastfeeding, please consult a healthcare professional before use. For children aged 6 to under 12 years, it's also advisable to check with a doctor before administering this medication.

Warnings and Precautions

It's important to be cautious when using this product. Do not use it if you are allergic to any of its ingredients. If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, consult your doctor before using this product. Always follow the recommended dosage and do not use it if you do not have nasal congestion. This product is not suitable for children under 6 years old.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your symptoms persist. If you are pregnant or breastfeeding, it's essential to consult a healthcare professional before using this product.

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 an overdose, it is crucial to seek immediate medical help.

In case of an emergency, 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

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering this medication for children. You should not use it for children under 6 years old. If your child is between 6 and 12 years old, it's best to consult with a doctor before use.

For children aged 12 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 it’s not used 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

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if there are existing health concerns such as heart disease, high blood pressure, thyroid issues, diabetes, or difficulty urinating due to an enlarged prostate. These conditions can affect how the medication works in your body.

For adults and children aged 12 and older (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril, but you should not use it more often than every 10 to 12 hours. It's crucial to avoid exceeding 2 doses within a 24-hour period to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations available for how your treatment may need to be altered 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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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). This helps maintain its effectiveness and integrity. It's also important to keep the original box, as it contains valuable information and labeling that you may need for future reference.

When handling the product, always do so with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication as a nasal spray, with the recommended dosage being 2 or 3 sprays in each nostril for adults and children aged 12 and older (with adult supervision). Make sure not to use it more than once every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period.

If your symptoms continue, stop using the medication and consult a doctor. It's important to talk to a healthcare professional before using this product if you are pregnant, breastfeeding, or have certain health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Additionally, consult a doctor before use for children aged 6 to under 12 years.

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.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older should use 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and should not exceed 2 doses in 24 hours.

Can children under 6 years use this drug?

No, this drug should not be used in children under 6 years. For children aged 6 to under 12 years, consult a doctor.

What should I do if I experience discomfort while using this drug?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and ask a doctor.

Are there any contraindications for using this drug?

Do not use this drug if you are allergic to the ingredients, do not have nasal congestion, or if you are under 6 years of age.

What precautions should I take before using this drug?

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 I accidentally swallow this drug?

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

Is there any information about teratogenic effects?

No teratogenic effects are mentioned for this drug.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

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 relief from sinus congestion and pressure.

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

Dosage and Administration

Adults and children aged 12 years and older, under adult supervision, are advised to administer 2 or 3 sprays in each nostril, with a frequency not exceeding every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period. For children aged 6 to under 12 years, consultation with a healthcare professional is recommended prior to use. This product is contraindicated in children under 6 years of age.

Prior to administration, the bottle should be shaken well. For first-time use, the protective cap must be removed, and any safety clip from the tip should be discarded. The metered pump should be primed by firmly depressing it several times.

For proper administration, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The head should remain upright while the nozzle is inserted into the nostril. The pump should be fully depressed with a firm, even stroke while the user sniffs deeply. After use, the nozzle should be wiped clean to maintain hygiene.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients with a known allergy to any of the ingredients.

  • Individuals without nasal congestion, as the product is intended for use specifically in this condition.

  • Children under 6 years of age, due to safety concerns.

  • Exceeding the recommended dosage is also contraindicated, as it may lead to adverse effects.

These contraindications are established to ensure patient safety and efficacy of the product.

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 urinary difficulties due to an enlarged prostate gland to consult a healthcare professional. It is imperative to adhere to the recommended dosage and not exceed it while using this product.

This product is contraindicated in the absence of nasal congestion and is not recommended for use in children under the age of 6 years.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients are advised to discontinue use and consult a healthcare provider if symptoms persist. Additionally, pregnant or breastfeeding individuals should seek guidance from a health professional before using this product.

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 imperative that patients do not use this product if they have known allergies to its components.

Before using this product, patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare professional. This precaution is essential to ensure the safe use of the product.

Patients are advised to discontinue use and seek medical advice if symptoms persist. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional prior to use to assess any potential risks.

For children aged 6 to under 12 years, it is recommended to consult a doctor before use to ensure safety and appropriateness of the product for this age group.

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 6 years of age should not use this medication. For children aged 6 to under 12 years, it is advised to consult a healthcare professional before use.

In adolescents and children aged 12 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 should consult a healthcare provider 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. These conditions may necessitate careful monitoring and potential dose adjustments to ensure safety and efficacy.

For adults and children aged 12 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 to note that the total dosage should not exceed 2 doses within a 24-hour period.

Given the potential for increased sensitivity to medications in geriatric patients, healthcare providers should exercise caution and consider individual patient factors when determining the appropriateness of this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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.

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 essential to inform patients not to use the product if they are allergic to any of its ingredients. Additionally, patients should be cautioned against using the product without nasal congestion, as it is contraindicated in such cases.

Providers should emphasize that the product is not recommended for children under 6 years of age. Patients should be instructed to stop using the product and consult a doctor if their symptoms persist. For those who are pregnant or breastfeeding, it is crucial to recommend consulting a health professional before use.

Patients must be reminded not to exceed the recommended dosage. After continuous use for 3 days, they should be advised to discontinue use for 1 day, following the instructions provided. It is important to highlight that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge. Providers should inform patients that using this container by more than one person may facilitate the spread of infection.

Furthermore, healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. For children aged 6 to under 12 years, it is advisable to seek a doctor's guidance before use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be retained for future reference on full labeling. It is essential to store the product at a temperature not exceeding 25°C to maintain its integrity and efficacy. Additionally, the original box should be kept for any necessary information regarding the product's labeling and handling instructions.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 12 years and older, it is recommended to administer 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, and to not exceed 2 doses within a 24-hour period.

Clinicians should counsel patients to discontinue use and consult a doctor if symptoms persist. Pregnant or breastfeeding patients are advised to seek guidance from a health professional prior to use. Additionally, patients with a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate should consult a doctor before use. For children aged 6 to under 12 years, a doctor's advice is also recommended.

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

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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.