PREFERRED PLUS 12 HOUR NASAL ORIGINAL- oxymetazoline hydrochloride spray 
Kinray

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

Warnings

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if symptoms persists.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

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

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PREFERRED PLUS 12 HOUR NASAL  ORIGINAL
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-048
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-048-021 in 1 CARTON
1NDC:61715-048-0130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/2008
Labeler - Kinray (012574513)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Kinray012574513label(61715-048)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432pack(61715-048)
Establishment
NameAddressID/FEIBusiness Operations
Samson Pharmaceuticals088169581manufacture(61715-048)

Revised: 3/2013
Document Id: 56013e78-1101-469b-a89c-714dcbe74947
Set id: 095bab26-e703-48fb-b59e-61e61bab789d
Version: 7
Effective Time: 20130325
 
Kinray