Label: AFRIN NO DRIP EXTRA MOISTURIZING- oxymetazoline hydrochloride spray, metered

  • NDC Code(s): 11523-1783-1, 11523-1783-2, 11523-1783-3
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2023

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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
    • 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 6 years of age: ask a doctor.

    Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. 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, benzyl alcohol, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or comments?

    Call 1-800-317-2165

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Bayer HealthCare LLC, Whippany, NJ, USA, 07981

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    11523-1783

  • INGREDIENTS AND APPEARANCE
    AFRIN NO DRIP  EXTRA MOISTURIZING
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1783
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1783-11 in 1 CARTON08/31/2000
    115 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:11523-1783-21 in 1 CARTON08/31/2000
    220 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:11523-1783-32 in 1 CARTON09/01/2022
    315 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/31/2000
    Labeler - Bayer HealthCare LLC. (112117283)
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