Your browser does not support JavaScript! PREFERRED PLUS 12 HOUR NASAL EXTRA MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [KINRAY]
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PREFERRED PLUS 12 HOUR NASAL EXTRA MOISTURIZING (oxymetazoline hydrochloride) spray
[Kinray]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Oxymetazoline Hydrochloride, 0.05%

Purpose

Nasal Decongestant

´╗┐Uses

  • Temporarily relieves nasal decongestion due to:  common cold, hay fever, sinusitis, upper respiratory allergies
  • Shrinks swollen nasal membranes so you can breathe more freely

Warnings

As a doctor before use if you have

  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland

When using this product

  • Do not use more than directed
  • Do not use for more than 3 days.  Use only as directed.  Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.
  • Use of this container by more than one person may spread infection.

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

  • Adults and children 6 to under 12 years of age (with adult supervision):  2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age:  ask a doctor
  • To spray, squeeze bottle quickly and firmly.  Do not tilt head backwards while spraying.  Wipe nozzle clean after use

Other information

  • Store between 20° - 25° C (68° - 77° F)
  • Retain carton for future reference on full labeling.

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 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
 
Kinray

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