Privine
FDA Label NDC 63736-662

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Privine (NDC 63736-662). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per spray), purpose, uses, when using this product, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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.

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)

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)

Principle Display Panel (20 mL spray carton)

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