Label: AFRIN ORIGINAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 11523-1167-2, 11523-1167-3, 11523-1167-4, 11523-1167-5, view more
    11523-1167-6
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 March 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

  • 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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

  • Other information

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

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

  • Questions or comments?

    Call 1-800-317-2165

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Afrin ®

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Original

    NASAL SPRAY

    Fast, Powerful

    Congestion

    Relief

    Colds • Allergies

    up to 12

    Hour

    Relief

    Maximum

    Strength

    #1 Doctor & Pharmacist

    Recommended Brand

    1/2 FL OZ (15 mL)

    Product carton label

  • INGREDIENTS AND APPEARANCE
    AFRIN  ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1167
    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
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1167-22 in 1 CARTON07/14/1975
    121 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:11523-1167-31 in 1 CARTON07/14/1975
    220 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:11523-1167-43 in 1 CARTON07/14/1975
    330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4NDC:11523-1167-51 in 1 CARTON07/14/1975
    430 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    5NDC:11523-1167-61 in 1 CARTON07/14/1975
    515 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 finalpart34107/14/1975
    Labeler - Bayer HealthCare LLC. (112117283)