Your browser does not support JavaScript! LEADER ORIGINAL NASAL (OXYMETAZOLINE HYDROCHOLORIDE) SPRAY [CARDINAL HEALTH]
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LEADER ORIGINAL NASAL (oxymetazoline hydrocholoride) spray
[CARDINAL HEALTH]


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                                                                   Purpose

Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

  • do not use more than directed
  • do not use 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 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.

Directions

  • adults and children 6 to 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, 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.

Other information

  • store between 15o and 25oC (59o and 77oF)
  • retain carton for future reference on full labeling

Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4584645

www.myleader.com

1-800-200-6313

Made in Korea

image of carton label

LEADER ORIGINAL NASAL 
oxymetazoline hydrocholoride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-735
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
POLYETHYLENE GLYCOL 400 
SODIUM PHOSPHATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-735-101 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 9/2012
 
CARDINAL HEALTH

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