OXYMETAZOLINE HYDROCHLORIDE - oxymetazoline hydrochloride spray, metered 
Zydus Pharmaceuticals USA Inc.

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Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray

ACTIVE INGREDIENT

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

■   Temporarily relieves nasal congestion due to:

                ■   a cold         ■   hay fever         ■  upper respiratory allergies

■   promotes nasal and sinus drainage

■   temporarily relieves sinus congestion and pressure

■   helps clear nasal passages; shrinks swollen membranes

WARNINGS

Ask a doctor before use if you have

■   heart disease         ■   high blood pressure         ■  thyroid disease        ■  diabetes

■   trouble urinating due to an enlarged prostate gland

When using this product

■   do not use more than directed

■   do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

■   temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur

■   use of this container 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

■   adults and children 6 to under 12 years of age (with adult supervision):
     2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

■   children under 6 years of age: ask a doctor.

Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Other information

■   Store between 20° - 25°C (68° - 77°F)

■   retain carton for future reference on full labeling

Inactive ingredients

Benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.

Manufactured by:

                              Cadila Healthcare Ltd.

                              Ahmedabad, India

Distributed by:

                              Zydus Pharmaceuticals USA Inc.

                              Princeton, NJ 08540

Rev.: 00/00

Revision Date: 08/17/2009

Container and Carton Labels

NDC 68382-418-07

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, 3/4 FL OZ (22 ml)

Rx only

Zydus

OXYMETAZOLINE HYDROCHLORIDE   oxymetazoline hydrochloride   spray, metered

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68382-418 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   CAMPHOR   EDETATE DISODIUM   EUCALYPTOL   GLYCINE   MENTHOL   POLYETHYLENE GLYCOL   POLYSORBATE 80   PROPYLENE GLYCOL   WATER   SODIUM CHLORIDE   SODIUM HYDROXIDE

Product Characteristics Color WHITE (COLORLESS) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68382-418-07 1 INHALER In 1 CARTON contains a INHALER 1 22 mL In 1 INHALER This package is contained within the CARTON (68382-418-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part341	09/24/2009

Labeler - Zydus Pharmaceuticals USA Inc. (156861945)

Registrant - Zydus Pharmaceuticals USA Inc. (156861945)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		918596198	Manufacture, Analysis

Revised: 08/2009Zydus Pharmaceuticals USA Inc.