Label: AFRIN ALLERGY SINUS NASAL- oxymetazoline hydrochloride spray

  • 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 May 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient Purpose

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

  • PURPOSE

  • INDICATIONS & USAGE

    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

    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 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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    • store between 20º to 25ºC (68º to 77ºF)
    • retain carton for future reference on full labeling
  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

  • QUESTIONS

    Questions or comments? 1-800-317-2165

  • 15 mL Carton

    Afrin

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Allergy Sinus

    Nasal Spray

    Fast, Powerful

    Congestion

    Relief From

    Allergies

    up to

    12 HOUR

    RELIEF

    Reduces

    Swelling of

    Nasal

    Packages

    #1 Doctor &

    Pharmacist Recommended

    Nasal Spray Brand

    1/2 FL OZ (15 mL)

    Carton 15 mL

  • INGREDIENTS AND APPEARANCE
    AFRIN ALLERGY SINUS NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0073
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0073-11 in 1 CARTON08/26/2016
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/26/2016
    Labeler - Bayer HealthCare LLC. (112117283)