Label: AFRIN NO-DRIP ALLERGY SINUS- oxymetazoline hydrochloride spray, metered

  • 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 May 13, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • PURPOSE

    Purpose

    Nasal decongestant

  • 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 DOCTOR

    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

    When using this product

    do not use more than directed

    ● do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

    ● temporary discomfort may occur 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

    Stop use and ask a doctor if symptoms persist

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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. 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. Secure cap after use.

  • OTHER SAFETY INFORMATION

    Other information

    · store between 20°C to 25°C (68° to 77°F)

    · retain carton for future reference on full labeling

  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or Comments

    Questions or comments? Call 1-800-317-2165

  • PRINCIPAL DISPLAY PANEL

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    AFRIN

    NoDrip

    Won't drip from nose or down throat

    Allergy Sinus

    Pump Mist

    Fast, Powerful

    Congestion

    Relief from

    Allergies

    up to 12 Hour Relief

    Reduces

    Swelling of

    Nasal

    Passages

    #1 Doctor & Pharmacist Recommended Nasal Spray Brand

    1/2FL OZ (15mL)

    ndallergysinus

  • INGREDIENTS AND APPEARANCE
    AFRIN NO-DRIP  ALLERGY SINUS
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-3220
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-3220-11 in 1 CARTON08/30/2016
    115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/30/2016
    Labeler - Bayer HealthCare LLC (112117283)