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Leader Extra Moisturizing Nasal

Medically reviewed on November 7, 2016

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05mg in 100mg
Labeler: Cardinal Health
NDC Code: 49781-042

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.

Active Ingredient                                                           Purpose

Oxymetazoline HCL 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

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 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
  • Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after each use and snap cap back onto the bottle.

Other information

  • store between 20° and 25°C (68° and 77°F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, disodium EDTA, distilled water, monobasic sodium phosphate, PEG 1450, PVP K30

Distributed By:

Cardinal Health

Dublin, Ohio 43017

Made in Korea

LEADER EXTRA MOISTURIZING NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-042
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, DIBASIC 
EDETATE DISODIUM 
WATER 
SODIUM PHOSPHATE, MONOBASIC 
POLYETHYLENE GLYCOL 1450 
POVIDONE K30 
Packaging
#Item CodePackage Description
1NDC:49781-042-011 BOTTLE, SPRAY in 1 CARTON
130 mg in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/29/2013
Labeler - Cardinal Health (097537435)

 
Cardinal Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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