Label: DERMFREE ORIGINAL NASAL- naphazoline hcl 1%original nasal spray

  • NDC Code(s): 84010-011-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Active Ingredient

    NaphazolineHCL 1%

  • 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

    use of this container by more than one person may spread infection

  • 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

  • Stop Use

    symptoms persist.

  • Ask Doctor

    children 2 to under 6 years.

  • Keep Oot Of Reach Of Children

    ifswallowed, 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,Glycerolmenthol,propylene glycol,etc.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DERMFREE ORIGINAL NASAL 
    naphazoline hcl 1%original nasal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIGLYCERIN (UNII: 3YC120743U)  
    MENTHOL (UNII: L7T10EIP3A)  
    BORNEOL (UNII: M89NIB437X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-011-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056manufacture(84010-011)
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