NASALUB NASAL RELIEF- oxymetazoline hcl spray 
Genomma Lab USA, 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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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.

Directions

Other information

Inactive ingredients

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

DISTRIBUTED BY:

GENOMMA LAB USA INC.

HOUSTON, TX 77027

MADE IN KOREA

image description

NASALUB NASAL RELIEF 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-065
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, 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:50066-065-301 in 1 CARTON11/07/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/02/2014
Labeler - Genomma Lab USA, Inc (832323534)

Revised: 11/2016
Document Id: f8d1488e-919d-496c-b1a6-e2090b6fe786
Set id: 20709ba2-6912-4e59-a671-ca1366038936
Version: 2
Effective Time: 20161107
 
Genomma Lab USA, Inc