ASSURED NASAL RELIEF  - oxymetazoline hydrochloride spray 
Greenbrier International, 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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Drug Facts

Active ingredient                                                                  Purpose

Oxymetazoline HCl..............................................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.

Directions

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 of carton label

ASSURED NASAL RELIEF  
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-8685
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 (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
POVIDONE K30 (UNII: U725QWY32X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-8685-11 in 1 TUBE
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/30/2013
Labeler - Greenbrier International, Inc. (610322518)

Revised: 4/2013
Document Id: e64cc0cf-0d97-4258-b16b-c1557c3f4c0e
Set id: 19cc7f79-f23c-4aab-b007-c41fb1a81799
Version: 3
Effective Time: 20130430
 
Greenbrier International, Inc.