ASSURED NASAL RELIEF- oxymetazoline hydrochloride spray 
United Exchange Corp.

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..............................................Nasal decongestant

Uses

temporarily relieves nasal congestion due to:

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.

Directions

Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tiliting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

Other information

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

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

image description

ASSURED NASAL RELIEF 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-387
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
POVIDONE K30 (UNII: U725QWY32X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-387-051 in 1 BOX10/05/2016
115 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 finalpart34111/20/2013
Labeler - United Exchange Corp. (840130579)

Revised: 10/2016
Document Id: d18f82b5-67b5-4264-a214-366aa128e51b
Set id: 1f74de91-13fe-49f3-8bb2-f6e1d7336cf2
Version: 2
Effective Time: 20161005
 
United Exchange Corp.