PRIVINE- naphazoline hydrochloride spray 
Insight Pharmaceuticals

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.

----------

Privine®
nasal spray

Drug Facts

Active ingredient (per spray)

Naphazoline HCl, USP 0.05%

Purpose

Nasal decongestant

Uses

for temporary relief of nasal congestion

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

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.

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
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)

Revised: 7/2009
Document Id: 2584355b-c068-4bca-87f6-7854da08610b
Set id: ec2bb7d7-d014-46ed-a836-453e921da4c5
Version: 1
Effective Time: 20090731
 
Insight Pharmaceuticals