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12 Hour Nasal by Healthlife of USA

Medically reviewed on January 2, 2018

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: Healthlife of USA
NDC Code: 69517-613

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.

12 Hour Nasal Spray
Nasal Decongestant

Drug Facts

Active Ingredient

Oxymetazoline HCL 0.05%

Purpose 

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

  • ´╗┐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 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 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 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 six years of age: ask a doctor.
  • To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information
  • store between 20°C to 40°C (68°F to 104°F)
  • retain carton for future reference on full labeling.

Inactive Ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, purified water.

Questions or Comments?

1-844-832-1138 Monday through Friday 9am-5pm

PRINCPAL DISPLAY PANEL - 15mL Bottle Carton

12 Hour Nasal Spray 

Nasal Decongestant 

Original 

0.5 Fl.OZ (15 mL)

12 HOUR NASAL 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-613
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 GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
WATER 
Packaging
#Item CodePackage Description
1NDC:69517-613-171 BOTTLE, PUMP in 1 CARTON
115 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2018
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Kingston Pharmaceuticals080386521manufacture(69517-613)

 
Healthlife of USA

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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