MAXIMUM STRENGTH NASAL DECONGESTANT- oxymetazoline spray liquid 
CVS Health

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.

if pregnant or breast-feeding 

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.

Directions

Other information

Inactive Ingredients

Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Panel 0.5 FLOZ Bottle

Principal Panel 0.5 FLOZ Bottle

CVS Health    Severe Congestion

Maxium Strength

Nasal Spray 

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal Panel 0.5 FLOZ Bottle

Principal Panel 0.5 FLOZ Bottle

Principal display panel- Bottle back label

Principal display panel- Bottle back labelPrincipal display panel- Bottle back labelPrincipal display panel- Bottle back label

Principal display panel -Carton

CVS Health Severe Congestion

Maxium Strength

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal display panel -Carton

Principal display panel -Carton

Principal display panel -Carton

MAXIMUM STRENGTH NASAL DECONGESTANT 
oxymetazoline spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-316
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTOL (UNII: RV6J6604TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-316-511 in 1 CARTON08/30/2018
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 finalpart34108/30/2018
Labeler - CVS Health (062312574)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceutical LLC151177797manufacture(69842-316)

Revised: 10/2018
Document Id: b9d7cb32-c78c-49b6-9cfb-10577f2a27ec
Set id: df1f8bda-7bf3-4755-9169-f2a81d824cbe
Version: 1
Effective Time: 20181023
 
CVS Health