OTC Labels

Over the Counter Medications

OTC Medication Information: Privine

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.

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.

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
(click image for full-size original)

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 missingor damaged.

0.66 fl oz (20mL)

Principle Display Panel -- 20 mL spray carton
(click image for full-size original)
PRIVINE naphazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-662
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naphazoline Hydrochloride (Naphazoline) Naphazoline 0.1 mL in 20 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride
sodium phosphate, dibasic
edetate disodium
sodium phosphate, monobasic
water
sodium chloride
Product Characteristics
Color WHITE (clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-662-02 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE
1 20 mL in 1 BOTTLE This package is contained within the BOX (63736-662-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/16/2009
Labeler — Insight Pharmaceuticals (176792315)

Revised: 07/2009 Insight Pharmaceuticals