WINCO FOODS SEVERE CONGESTION NASAL RELIEF- 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

Ask a doctor before use if you have

When using this product

do not use more than directed

Stop use and ask a doctor if symptoms persist.

If pregnant or breast-feeding, ask ahealth professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control center right away.

Directions

Other information

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, DL-camphor, eucalyptol, l-menthol, monobasic sodium phosphate dihydrate, polysorbate 80, propylene glycol

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

image description

WINCO FOODS SEVERE CONGESTION NASAL RELIEF 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-192
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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-192-301 in 1 CARTON11/02/2016
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 11/2016
Document Id: e4ea4184-3a63-42ed-b454-d4ad2724ff4c
Set id: 4a9656d9-1693-49e2-8a0e-04856be0f5c1
Version: 2
Effective Time: 20161102
 
WinCo Foods, LLC