Label: DERMFREE ORIGINAL NASAL- naphazoline hcl 0.05%original nasal spray

  • NDC Code(s): 84010-058-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Naphazoline HCL0.05%

  • Purpose

    Nasal Decongestant

  • Use

    temporarily relieves

    ·Nasal congestion due to a cold, hay fever, or other upper respiratory allergies

    ·Sinus congestion and pressure

  • Warnings

    1.Do not use if you are allergic to the ingredients.

    2.Ask a doctor before use if you have
    Heart disease、High blood pressure、Thyroid disease、Diabetes、Trouble urinating due to enlarged prostate gland 3.When using this product
    ·Do not exceed recommended dosage
    ·Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
    ·Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur.
    ·Use of this container by more than one person may spread infection.

  • Do not use

    ·Do not use this product for more than 3 days.Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

    ·Temporary discomfort such as burning,stinging,sneezing,or increased nasaldischarge may occur.
    ·Use of this container by more than one person may spread infection.

    children under 2 years.

  • When Using

    ·Do not exceed recommended dosage
    ·Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
    ·Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur.
    ·Use of this container by more than one person may spread infection.

  • Stop Use

    Stop use and ask a doctor if symptoms persist

  • Ask Doctor

    children 2 to under 6 years.

  • Keep Oot Of Reach Of Children

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

  • Directions

    Adults&children 6 years & older(with adult supervision ): 2 or 3 sprays in each nostril,not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours.
    Ask a doctor: children 2 to under 6 years,
    Do not use children under 2 years.

    Shake well before use. Before using the first time, remove the protective cap & safely clip from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depresspump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

  • Other information

    do not exceed 25°C.Retain the box for future reference on full labeling

  • Inactive ingredients

    Borneol,Camphor,glycerin,propylene glycol

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DERMFREE ORIGINAL NASAL 
    naphazoline hcl 0.05%original nasal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-058
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HCL (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HCL0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BORNEOL (UNII: M89NIB437X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-058-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/19/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056manufacture(84010-058)