PREFERRED PLUS 12 HOUR NASAL EXTRA MOISTURIZING- 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

As 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.  If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

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

image of label

image of carton

PREFERRED PLUS 12 HOUR NASAL  EXTRA MOISTURIZING
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-047
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 50.0 mg  in 100.0 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:61715-047-02 1 in 1 CARTON
1 NDC:61715-047-01 30 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/31/2008
Labeler - Kinray (012574513)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
Name Address ID/FEI Business Operations
Kinray 012574513 label(61715-047)
Establishment
Name Address ID/FEI Business Operations
Lee Pharmaceuticals 056425432 pack(61715-047)
Establishment
Name Address ID/FEI Business Operations
Samson Pharmaceuticals 088169581 manufacture(61715-047)

Revised: 7/2013
Document Id: 7ebe00a6-b1e0-46a9-8fe2-b5af851daa7d
Set id: c7704393-a519-4be0-a214-02ee82edf52d
Version: 1
Effective Time: 20130718
 
Kinray