Label: HEALTH MART NASAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 62011-0080-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated July 7, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    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
    •
    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 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 (1-800-222-1222).

  • 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 Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    retain carton for future reference on full labeling
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Afrin® active ingredient

    MAXIMUM STRENGTH

    Nasal Spray

    Oxymetazoline HCl 0.05% - Nasal Decongestant

    Original

    12 Hour Relief

    Fast, Powerful Congestion Relief

    Colds

    Allergies

    Gluten Free

    1 Fl oz (30 mL)

    304-w6-nasal-spray
  • INGREDIENTS AND APPEARANCE
    HEALTH MART NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0080
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (Translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0080-11 in 1 CARTON01/12/2012
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/12/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!