Label: SINUFRIN PLUS NEILMED- oxymetazoline hydrochloride spray 

  • NDC Code(s): 13709-232-05, 13709-232-06
  • Packager: NeilMed Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active Ingredients

    0.05% Oxymetazoline Hydrochloride

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  • 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.
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  • 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

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  • Uses

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

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  • Other Information

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


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  • Warnings

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

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  • 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.

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  • Other Information

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

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  • Warnings

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

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  • 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.

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  • Inactive ingredients

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

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  • Principle Display

    Imag of BottleImage of bottle

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  • Box Label
  • uses

    temporarily relieves nasal congestion due to:

    common cold

    sinusitis

    hay fever

    upper respiratory allergies

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  • INGREDIENTS AND APPEARANCE
    SINUFRIN PLUS  NEILMED
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:13709-232
    Route of Administration NASAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxymetazoline Hydrochloride (OXYMETAZOLINE) Oxymetazoline Hydrochloride 7.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    Benzalkonium Chloride  
    Propylene Glycol  
    Sodium Chloride  
    water  
    Sodium Bicarbonate  
    Glycerin  
    Aloe  
    Allantoin  
    Hydrochloric Acid  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13709-232-06 15 mL in 1 BOTTLE
    2 NDC:13709-232-05 15 mL in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/15/2012
    Labeler - NeilMed Pharmaceuticals, Inc. (783557783)
    Establishment
    Name Address ID/FEI Business Operations
    NeilMed Pharmaceuticals, Inc. 783557783 manufacture(13709-232)
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