Label: SINUFRIN NEILMED- oxymetazoline hydrochloride spray

  • NDC Code(s): 13709-231-04, 13709-231-07
  • 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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  • Uses

    temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

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  • Warnings

    Do not exceed recommended dosage. 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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  • 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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  • 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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  • 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. Adult males with prostate disease, do not use this product.

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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 using this product for more than 3 consecutive days. Stop and ask your doctor if symptoms of nasal congestion persist after using 3 consecutive days.

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  • Warnings

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

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  • Uses

    temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies.

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  • Inactive Ingredients

    Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water

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  • Principal Display label
  • Box label
  • INGREDIENTS AND APPEARANCE
    SINUFRIN  NEILMED
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:13709-231
    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
    SODIUM CHLORIDE  
    SODIUM BICARBONATE  
    PROPYLENE GLYCOL  
    EDETATE DISODIUM  
    BENZALKONIUM CHLORIDE  
    WATER  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13709-231-07 15 mL in 1 BOTTLE
    2 NDC:13709-231-04 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)
    Registrant - NeilMed Pharmaceuticals Inc (783557783)
    Establishment
    Name Address ID/FEI Business Operations
    NeilMed Pharmaceuticals Inc 783557783 manufacture(13709-231)
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