WINCO FOODS ORIGINAL NASAL- oxymetazoline hcl spray 
WinCo Foods, LLC

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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Active Ingredient                                                                                                            Purpose

Oxymetazoline HCL 0.05%-----------------------------------------------------------------------  Nasal decongestant

Uses

Warnings

Ask a doctor before use if you have

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.

Direction

Other information

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30

DISTRIBUTED BY:

WINCO FODDS, LLC,

BOISE, ID 83704

MADE IN KOREA

image description

WINCO FOODS ORIGINAL NASAL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-193
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-193-301 in 1 CARTON
130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/26/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 12/2014
Document Id: 70dd3aef-3b10-4c0b-a720-a28fadcf299e
Set id: b387ec58-b3d1-4ac9-87c0-a0147383e6b7
Version: 2
Effective Time: 20141212
 
WinCo Foods, LLC