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

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image of carton

PREFERRED PLUS 12 HOUR NASAL  EXTRA MOISTURIZING
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-047
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE50.0 mg  in 100.0 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM ANHYDROUS 
GLYCERIN 
POLYETHYLENE GLYCOL 3350 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-047-021 in 1 CARTON
1NDC:61715-047-0130 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(61715-047)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432pack(61715-047)
Establishment
NameAddressID/FEIBusiness Operations
Samson Pharmaceuticals088169581manufacture(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