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

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.

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

ACTIVE INGREDIENT

Oxymetazoline hydrochloride 0.05%

PURPOSE

Nasal decongestant

USES

                                   ■ a cold ■ hay fever ■ upper respiratory allergies

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

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

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.

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

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.

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

Oxymetazoline hcl nasal spray, 3/4 Fl OZ (22 mL)-image1
Oxymetazoline hcl nasal spray, 3/4 Fl OZ (22 mL)-image2
OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68382-418
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (COLORLESS) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68382-418-071 in 1 CARTON
122 mL in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34109/24/2009
Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198Analysis, Manufacture

Revised: 5/2011
Document Id: f98fc905-f9bc-4237-b193-e5be2977df46
Set id: d3ecb8ca-1e02-4dbe-8858-e801b76809e4
Version: 2
Effective Time: 20110525
 
Zydus Pharmaceuticals (USA) Inc.