Label: PRIVINE- naphazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 31, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per spray)

    Naphazoline HCl, USP 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    for temporary relief of nasal congestion

    • due to a cold
    • due to hay fever or other upper respiratory allergies
    • shrinks swollen membranes so you can breathe more freely
  • Warnings

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not exceed recommended dosage
    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
    • do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
    • use only as directed

    Stop use and ask a doctor if symptoms persist

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and over: 1 or 2 sprays in each nostril not more often than every 6 hours.
    • children under 12 years of age: consult a doctor.
  • Other information

    store at room temperature 20°–25°C (68°–77°F).

  • Inactive Ingredients

    benzalkonium chloride, dibasic sodium phosphate, disodium edetate, monobasic sodium phosphate, purified water and sodium chloride.

  • Questions

    Call 1-800-344-7239 or write to Consumer Affairs.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 20 mL spray label

    69853C
    LF-572

    FAST RELIEF
    OF STUFFY NOSE

    Privine®
    nasal spray
    naphazoline HCl, USP
    Nasal Decongestant

    Do not use if the plastic band on the
    bottle cap is missing or damaged.
    Store between 20°–25°C (68°–77°F).

    0.66 fl oz (20 mL)

    Principle Display Panel - 20 mL spray label
  • PRINCIPAL DISPLAY PANEL - 20 mL spray carton

    Fast
    relief
    of
    stuffy
    nose

    Privine®
    nasal spray
    naphazoline HCl, USP
    Nasal Decongestant

    Important:
    Do not use if
    the plastic band
    on the bottle
    cap is missing
    or damaged.

    0.66 fl oz (20mL)

    Principle Display Panel - 20 mL spray carton
  • INGREDIENTS AND APPEARANCE
    PRIVINE 
    naphazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-662
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline0.1 mL  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    sodium phosphate, dibasic (UNII: GR686LBA74)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium phosphate, monobasic (UNII: 3980JIH2SW)  
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-662-021 in 1 BOX
    120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/16/2009
    Labeler - Insight Pharmaceuticals (176792315)
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