Label: OXYMETAZOLINE HYDROCHLORIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 31, 2011

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  • ACTIVE INGREDIENT

    Oxymetazoline hydrochloride 0.05%

  • PURPOSE

    Nasal decongestant

  • USES

    • Temporarily relieves nasal congestion due to:

                                       ■ a cold ■ hay fever ■ upper respiratory allergies

    • promotes nasal and sinus drainage
    • temporarily relieves sinus congestion and pressure
    • helps clear nasal passages; shrinks swollen membranes
  • WARNINGS

    Ask a doctor before use if you have

    ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes

    ■ trouble urinating due to an 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
  • SPL UNCLASSIFIED SECTION

    Stop use and ask a doctor if symptoms persist.

  • SPL UNCLASSIFIED SECTION

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

  • Keep out of 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: ask a doctor.

    Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

  • Other information

    • Store between 20º - 25ºC (68º - 77ºF)
    • retain carton for future reference on full labeling
  • Inactive ingredients

    benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Cadila Healthcare Ltd.

    Ahmedabad, India

    Rev.: 00/00

    Revision Date: 05/31/2011

  • Container and Carton Labels

    NDC 65841-711-07

    Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)

    Rx only

    Zydus

    Oxymetazoline hcl nasal spray, 3/4 Fl OZ (22 mL)-image1
    Oxymetazoline hcl nasal spray, 3/4 Fl OZ (22 mL)-image2
  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HYDROCHLORIDE 
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65841-711
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCINE (UNII: TE7660XO1C)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    Product Characteristics
    ColorWHITE (COLORLESS) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-711-071 in 1 CARTON
    122 mL in 1 INHALER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34109/24/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198Analysis, Manufacture
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