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

  • NDC Code(s): 84010-057-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Naphazoline HCL 0.05%

  • Purpose

    Nasal Decongestant

  • Use

    temporarily relieves
    ·nasal congestion due to a cold, hay fever, or other upper respiratory allergies
    ·sinus congestion and pressure

  • Warnings

    Ask a doctor before use if you have
    ·heart disease
    ·high blood pressure
    ·thyroid disease
    ·diabetes
    ·trouble urinating due to enlarged prostate gland

  • Do not use

    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. Frequentor prolonged use may cause nasal congestion to recur or worsentemporary discomfort such as burning, stinging,sneezing, or increased nasaldischarge may occur
    ·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

    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 yrs.& older (with adult supervision)2 or 3 sprays in eachnostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours

  • Other information

    do not exceed 25°C

  • Inactive ingredients

    borneol,Camphor,glycerin,Glycerol,menthol,propylene glycol,etc.

  • 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:84010-057
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BORNEOL (UNII: M89NIB437X)  
    DIGLYCERIN (UNII: 3YC120743U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-057-0130 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(84010-057)
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