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

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
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

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 finalpart34105/30/2014
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-140)

Revised: 11/2021
Document Id: 8ad4f11a-aa91-41ed-adcf-04fb02e0ed6e
Set id: cea0ce76-ae75-4484-a7c2-ff1086e9d8b0
Version: 4
Effective Time: 20211118
 
Sheffield Pharmaceuticals LLC