Label: NASAL MIST CVS- oxymetazoline hydrochloride 0.05% 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 7, 2017

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  • Active ingredient                                       Purpose

    Oxymetazoline Hydrochloride 0.05%        Nasal decongestant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of nasal congestion due to
    the common cold, hay fever or other upper respiratory
    allergies

    • shrinks swollen membranes so you can breathe
    more freely

  • 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 exceed recommended dosage • do not use for more than 3 days. Use only as directed. • 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 • frequent or prolonged use may cause nasal congestion to recur or worsen

    Stop use and ask a doctor if symptoms persist

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

  • Directions

    Before using the first time, remove the protective cap from the tip and prime pump by depressing pump 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 rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. • adults and children 6 to under1 2 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 1 0 to 1 2 hours. Do not exceed 2 doses within any 24-hour period • children under 6 years of age: consult a doctor

  • Inactive ingredients


    Benzalkonium Chloride, Benzyl Alcohol, Camphor, Edetate Disodium, Eucalyptol, Menthol, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    NASAL MIST  CVS
    oxymetazoline hydrochloride 0.05% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-387
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Eucalyptol (UNII: RV6J6604TK)  
    Menthol (UNII: L7T10EIP3A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Povidone (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-387-011 in 1 CARTON10/01/2015
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2015
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-387)
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