Label: AFRIN NO DRIP PUMP MIST BUNDLE PACK- oxymetazoline hydrochloride kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 23, 2024

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

  • 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.

    To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, 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

    No Drip Original

    benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

    No Drip Night

    benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

  • Questions or comments?

    Questions or comments? 1-800-317-2165

  • PRINCIPAL DISPLAY PANEL - Bundle Pack Carton

    Bundle Pack Label

    BUNDLE PACK 2 X 15 mL Bottles

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Afrin ®

    No Drip

    Original

    NASAL PUMP MIST

    • Relieves Nasal Congestion & Sinus Congestion/Pressure

    Unblocks in

    SECONDS*

    Lasts 12 HRS

    1/2 FL OZ (15 mL)

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Afrin ®

    No Drip

    Night

    NASAL PUMP MIST

    • Nasal Congestion Relief for a More Restful Night
    • Chamomile Scent

    Unblocks in

    SECONDS*

    Lasts 12 HRS

    1/2 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    AFRIN NO DRIP  PUMP MIST BUNDLE PACK
    oxymetazoline hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0147
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0147-11 in 1 CARTON; Type 0: Not a Combination Product04/19/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, SPRAY 15 mL
    Part 21 BOTTLE, PUMP 15 mL
    Part 1 of 2
    AFRIN NO DRIP  ORIGINAL PUMP MIST
    oxymetazoline hydrochloride spray, metered
    Product Information
    Item Code (Source)NDC:11523-3142
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/31/1999
    Part 2 of 2
    AFRIN NO DRIP NIGHT  CHAMOMILE
    oxymetazoline hydrochloride spray, metered
    Product Information
    Item Code (Source)NDC:11523-1160
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 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 DrugM01208/31/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/19/2024
    Labeler - Bayer HealthCare LLC. (112117283)