PRIVINE- naphazoline hydrochloride spray

Privine by

Drug Labeling and Warnings

Privine by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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)

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)

INGREDIENTS AND APPEARANCE

PRIVINE 
naphazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-662
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)	Naphazoline	0.1 mL  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-662-02	1 in 1 BOX
1		20 mL in 1 BOTTLE

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)