PRIVINE- naphazoline hydrochloride suspension/ drops 
Insight Pharmaceuticals LLC

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.

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Privine®
nasal drops

Drug Facts

Active ingredient (per drop)

Naphazoline HCl, USP 0.05%

Purpose

Nasal decongestant

Uses

for the temporary relief of nasal congestion

Warnings

Do not use this product in children under 12 years of age because it may cause sedation if swallowed.

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. Use only as directed. Frequent or prolonged use may cause nasal congestion to come back or get worse.
  • the use of this container or dropper by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

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

Inactive Ingredients

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

Questions

Call 1-800-344-7239

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

PRINCIPAL DISPLAY PANEL - 25 mL Drops Carton

Fast
relief
of
stuffy
nose

Privine®
nasal drops

naphazoline HCl, USP
Nasal Decongestant

Important: Do not use if seal under bottle cap imprinted
with "Sealed for your protection" is missing or broken.

0.83 fl oz (25mL)

PRINCIPAL DISPLAY PANEL - 25 mL Drops Carton
PRIVINE 
naphazoline hydrochloride suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-663
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.125 mL  in 25 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:63736-663-011 in 1 BOX
125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/16/2009
Labeler - Insight Pharmaceuticals LLC (176792315)

Revised: 1/2011
Document Id: 8541b271-ccd6-4c6d-9797-60335e7e4d22
Set id: ac1410ce-ae7f-498d-b84c-a6d32e1c87a6
Version: 2
Effective Time: 20110131
 
Insight Pharmaceuticals LLC