OXYMETAZOLINE HCL- oxymetazoline hcl spray 
NuCare Pharmaceuticals,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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Major Pharmaceuticals Nasal Decongestant Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

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 (1-800-222-1222).

Directions

To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Other information

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions or comments?

1-800-616-2471

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OXYMETAZOLINE HCL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2810(NDC:0904-6761)
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Product Characteristics
Colorwhite (to off white, viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2810-11 in 1 CARTON08/09/2022
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 finalpart34110/12/2018
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-2810)

Revised: 8/2022
Document Id: e5d62463-4073-3851-e053-2995a90aa758
Set id: e5d62463-4074-3851-e053-2995a90aa758
Version: 1
Effective Time: 20220809
 
NuCare Pharmaceuticals,Inc.