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Decongestant Nasal

Dosage form: solution
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: Salado Sales Inc.
NDC Code: 57243-036

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


Oxymetazoline HCl 0.05%

Purpose
Oxymetazoline HCl............... Nasal decongestant

Uses
 temporarily relieves nasal congestion due to:
     common cold      hay fever
     upper respiratory allergies
 temporarily relieves sinus congestion and pressure
 shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

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

When using this product
 do not exceed recommended dosage
 temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
 do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to recur or worsen.
 use only as directed
 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
 to spray, squeeze bottle quickly and firmly
 do not tilt head backward while spraying
 wipe nozzle clean after use
 do not exceed 2 doses in any 24-hour period

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

children under 6 years of age: ask a doctor

Other information

 RETAIN CARTON FOR FUTURE REFERENCE ON FULL LABELING
 store between 2°-30°C (36°-86°F)

Inactive ingredients
benzalkonium chloride 0.01%, edetate disodium, polyethylene glycol 1450, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

DECONGESTANT NASAL 
oxymetazoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-036
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 1450 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
water 
Packaging
#Item CodePackage Description
1NDC:57243-036-101 BOTTLE, DISPENSING in 1 CARTON
130 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2000
Labeler - Salado Sales Inc. (009830555)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, Inc.174450460manufacture(57243-036), label(57243-036), pack(57243-036)

Revised: 02/2016
 
Salado Sales Inc.

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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