Label: NASAL- oxymetazoline hydrochloride

  • NDC Code(s): 73169-002-01
  • Packager: DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.
  • 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 June 7, 2019

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

  • Active ingredient                   Purpose

       Oxymetazoline hydrochloride 0.05% Nasal Decongestant

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  • Uses

    For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
    temporary relieves sinus congestion and pressure
    shrinks swollen nasal membranes so you can breathe more freely

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  • Warnings

    Ask a doctor before use if you have

    heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to 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.

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  • 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 at 1-800-222-1222

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  • 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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
    Other information
    store at room temperature.

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  • Inactive ingredients

    Benzalkonium Chloride, benzyl Alcohol, edetate disodium, polyethylene glycol, Povidone, propylene glycol, Purified water, Sodium Phosphate dibasic, Sodium Phosphate monobasic.

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  • INGREDIENTS AND APPEARANCE
    NASAL 
    oxymetazoline hydrochloride kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:73169-002
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:73169-002-01 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 06/07/2019
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 3
    Part 4
    Part 1 of 4
    NO MORE NOSEBLEED 
    oxymetazoline hydrochloride liquid
    Product Information
    Item Code (Source) NDC:73169-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341
    Part 2 of 4
    SODIUM CHLORIDE 0.65% - NASALSALINE SPRAY 
    moisturizing
    Product Information
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic
    Part 3 of 4
    VASELINE PETROLEUM JELLY 
    moisturizing
    Product Information
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic
    Part 4 of 4
    BLEEDCEASE 
    other personal cleanliness products
    Product Information
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/07/2019
    Labeler - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)
    Registrant - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364)
    Establishment
    Name Address ID/FEI Business Operations
    DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. 117075364 manufacture(73169-002)
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