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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
85248-111
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, as well as sinus congestion and pressure. It works by helping to clear your nasal passages, making it easier for you to breathe.

If you're experiencing discomfort from nasal congestion, this medication can provide you with the relief you need to feel more comfortable. Always consult with a healthcare professional for guidance on how to use it effectively.

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

When using this medication, you will administer it as a spray in each nostril. For adults and children aged 12 years and older, you can use 2 or 3 sprays in each nostril, but make sure to wait at least 10 to 12 hours before using it again. It's important not to exceed 2 doses within a 24-hour period.

If you are 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. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product carefully to ensure your safety and well-being. You should not use it for more than three days, and always follow the directions provided. Using it too frequently or for an extended period can lead to worsening nasal congestion. You might experience some temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge.

Additionally, avoid sharing this container with others, as it can spread infections. If you have children under the age of 6, do not use this product for them. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

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. If you experience persistent symptoms, you should stop using the medication and seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Additionally, if the user is a child aged 6 to under 12 years, it's advisable to ask a doctor before use.

Warnings and Precautions

Before using this product, 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. This product should not be used for more than three days, as extended use 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, and it is not suitable for children under six 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 consult your doctor if your symptoms persist. If you are pregnant or breastfeeding, please speak with 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 always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek immediate medical help. It’s crucial to contact your healthcare provider or go to the nearest emergency room for assistance. Always remember to keep medications out of reach of children and follow the prescribed dosage to ensure your safety.

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 using this product 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 using the product.

For children aged 12 and older, and with adult supervision, the recommended dosage is 2 or 3 sprays in each nostril, but this should not happen more often than every 10 to 12 hours. Remember, they should 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, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the 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 on 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 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 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 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, make sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that your hands and any surfaces are clean to maintain a sterile environment. Proper storage and careful handling are key to ensuring the product works as intended.

Additional Information

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

If you are considering this medication for children aged 6 to under 12 years, it's important to consult a doctor first. This medication is not recommended for children under 6 years old.

FAQ

What is the purpose of this medication?

This medication 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 times in 24 hours.

Can this medication be used in children under 6 years?

No, this medication should not be used in children under 6 years. For children 6 to under 12 years, consult a doctor before use.

What should I do if symptoms persist?

If symptoms persist, stop use and ask a doctor for further advice.

Are there any warnings I should be aware of?

Yes, 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 are some possible side effects of this medication?

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

How long can I use this medication?

Do not use this product for more than 3 days, and use only as directed to avoid worsening nasal congestion.

What should I do if I accidentally swallow this medication?

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

Is it safe to use this medication during pregnancy or while 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 hcl0.05%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. It also 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. This should not occur more frequently than every 10 to 12 hours, and the total administration should not exceed 2 times within a 24-hour period.

For children aged 6 to under 12 years, it is recommended to consult a healthcare professional before use. The product is contraindicated in children under 6 years of age.

The route of administration is intranasal, utilizing a spray method. Care should be taken to adhere to the specified dosing intervals to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should not be used for more than 3 days, as prolonged use may lead to rebound nasal congestion.

  • It is contraindicated for individuals under 6 years of age due to safety concerns.

  • Use only as directed; misuse may exacerbate symptoms or lead to adverse effects.

  • Frequent or prolonged use may cause nasal congestion to recur or worsen.

  • Temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge, may occur; however, these effects do not warrant continued use.

  • Sharing this container among multiple users is contraindicated due to the risk of spreading infection.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. Prior to use, patients should be advised to consult a physician 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.

This product is intended for short-term use only. It should not be used for more than three consecutive days, and it must be used strictly as directed. Prolonged or frequent 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. Additionally, sharing this product among multiple users may pose a risk of infection transmission. It is contraindicated for use in children under the age of six.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare provider if symptoms persist. Furthermore, pregnant or breastfeeding individuals should seek professional medical advice before using this product.

Side Effects

Patients should be aware of several important warnings and recommendations regarding the use of this medication. It is advised that individuals 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, pregnant or breastfeeding individuals should consult a healthcare professional before using this medication to ensure safety for both the mother and child.

For children aged 6 to under 12 years, it is recommended to seek guidance from a doctor before administration. These precautions are essential to mitigate potential risks associated with the use of this medication.

Drug Interactions

There are currently no documented drug interactions associated with 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 hcl0.05%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 product. For children aged 6 to under 12 years, it is advised to consult a doctor prior to use.

For adolescents 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, and should not exceed 2 doses within a 24-hour period. Adult supervision is required for this age group.

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

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 regarding the excretion of this medication 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 may not have specific dosage adjustments or monitoring requirements outlined in the prescribing information. As such, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, given the absence of detailed guidance on the management of this population. Regular assessment of renal function is advisable to ensure safe and effective use of the medication in these patients.

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

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised 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 should not be used for more than three days and must be used only as directed. They should be made aware that 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 an increase in 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 advise patients who are pregnant or breastfeeding to consult a health professional before using this product.

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 12 years and older, it is recommended to use 2 or 3 sprays in each nostril, with a frequency not exceeding every 10 to 12 hours and a maximum of 2 times within a 24-hour period. Clinicians should advise patients to consult a doctor before use in children aged 6 to under 12 years, and it is contraindicated for children under 6 years of age.

No additional information is available regarding laboratory tests, abuse potential, 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.