OXYMETAZOLINE HYDROCHLORIDE spray, metered

OXYMETAZOLINE HYDROCHLORIDE by

Drug Labeling and Warnings

OXYMETAZOLINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if symptoms persist.

SPL UNCLASSIFIED SECTION

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 20º - 25ºC (68º - 77ºF)
• 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.

SPL UNCLASSIFIED SECTION

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 05/11

Revision Date: 05/31/2011

Container and Carton Labels

NDC: 68382-418-07

Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)

Rx only

Zydus

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray, metered

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
GLYCINE (UNII: TE7660XO1C)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68382-418-07	1 in 1 CARTON
1		22 mL in 1 INHALER

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	Business Operations
Cadila Healthcare Limited		918596198	Analysis, Manufacture