Label: 12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid

  • 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 December 10, 2020

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

  • Active Ingredient

    Oxymetazoline HCl 0.05%

    Purpose

    Nasal Decongestant

  • Uses

    Tempoarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • sinusitis
    • upper respiratory allergies

    Shrinks swollen membranes so you can breathe more freely.

  • Warnings

    Ask a doctor before use if you have

    • heart diease
    • high blood pressure
    • diabetes
    • thyiod diease
    • trouble urinating due to enlarged rostate gland.

    When using this product

    • do not use more than directed
    • do not use for more than three 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.

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

  • Directions

    • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more 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

    To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying. Wipe nozzle clean after use.

  • Other information

    • store at a controlled room temperature 20°-25°C (68°-77°F)
    • keep card for future reference on full labeling

  • Inactive ingredients

    Benzalkonium Chloride, Disodium EDTA, Disodium Phosphate, Glycerin, PEG-6, Propylene Glycol, PVP, Sodium Phosphate, Water (Purified)

  • Principal Dipslay Panel

    Nasal Spray

  • INGREDIENTS AND APPEARANCE
    12 HOUR ORIGINAL NASAL DECONGESTANT 
    nasal spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-209(NDC:11527-140)
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE50 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-209-011 in 1 PACKAGE12/10/2020
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/10/2020
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Registrant - Navajo Manufacturing Company Inc. (136941411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-209) , repack(67751-209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(67751-209)