12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid 
Sheffield Pharmaceuticals LLC

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Sheffield 12HR Nasal Spray 

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily 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.

ask a health professional before use.

Keep out of the reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Other information

Inactive Ingredients:

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal display panel- Bottle

Sheffield Pharmaceutical          NDC 11527-140-55

Original Nasal Spray 

Oxymetazoline HCL 0.05%

12hour relief of Nasal congestion due to:

30 mL  (1.01 FL OZ)

Nasal Spray Front label bottle 1 OZ

Principal display panel- Bottle back label

Principal display panel- Bottle back label

Principal display panel- Bottle back label

Nasal Spray Front label bottle 1 OZ

Principal display panel -Carton

Sheffield Pharmaceuticals                           NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12 hour relief of Nasal congestion due to:

30 mL (1.01 FL OZ)

Principal display panel -Carton

12 HOUR ORIGINAL NASAL DECONGESTANT 
nasal spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-140
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE50 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-140-551 in 1 CARTON05/30/2014
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 DrugM01205/30/2014
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-140)

Revised: 10/2023
Document Id: 36eb3a35-be6c-4e5f-a189-2575f5dd142b
Set id: cea0ce76-ae75-4484-a7c2-ff1086e9d8b0
Version: 5
Effective Time: 20231030
 
Sheffield Pharmaceuticals LLC