ASSURED SEVERE CONGESTION 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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Assured Nasal Spray Severe Congestion 0.5 oz (21528, 2019) DZ

Active ingredient                                                      Purpose

Oxymetazoline HCL 0.05%....................................... 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. Remove safety seal. 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 tilting 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, camphor edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate, monobasic monohydrate

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in China

21528.1

ASSURED SEVERE CONGESTION NASAL RELIEF 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-5284
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.2 mg  in 0.4 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-5284-51 in 1 BOX11/03/2016
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 finalpart34105/14/2015
Labeler - Greenbrier International, Inc (610322518)

Revised: 5/2019
Document Id: 87dcceb6-e500-cbbe-e053-2995a90aaf0a
Set id: cd92b4f4-f003-4328-b144-b979cb437216
Version: 5
Effective Time: 20190501
 
Greenbrier International, Inc