Label: SINUFRIN PLUS NEILMED- oxymetazoline hydrochloride spray

  • NDC Code(s): 13709-232-05, 13709-232-06, 13709-232-12
  • Packager: NeilMed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    0.05% Oxymetazoline Hydrochloride

  • Warnings

    • Do not use this product for more than 3 consecutive days.Use only as directed.
    • Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
    • Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.
  • Directions for Dosing

        * Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor

  • Uses

    Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.

  • Other Information

    Store between 20 to 40 °C (68 to 104 °F)
    Retain carton for future reference on full labeling


  • Warnings

    KEEP OUT OF REACH OF CHILDREN. If Swallowed,get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    Do not use this product for more than 3 consecutive days.

    Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.

  • Other Information

    • Keep head in an upright position for use.
    • Do not tilt head backward while spraying.
    •  Wipe nozzle clean after each use.
  • Warnings

    Stop use and ask a doctor if symptoms of nasal congestion persist after 3 days.

    Adult males with prostate disease, do not use this product.

  • Warnings

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

  • Warnings

    This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
    The use of this container by more than one person may spread infection.

  • Inactive ingredients

    Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified water

  • uses

    temporarily relieves nasal congestion due to:

    common cold

    sinusitis

    hay fever

    upper respiratory allergies

  • Principle Display

    Imag of Bottle Image of bottle

  • Box Label

    Box label

  • INGREDIENTS AND APPEARANCE
    SINUFRIN PLUS  NEILMED
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-232
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE7.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-232-0615 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)07/15/2012
    2NDC:13709-232-0515 mL in 1 BOX; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)07/15/2012
    3NDC:13709-232-121 in 1 CARTON04/21/2021
    330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2012
    Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-232)