Label: TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 3, 2023

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  • Active ingredient

    Oxymetazoline HCl 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves

    •
    nasal congestion due to a cold, hay fever, or other upper respiratory allergies
    •
    sinus congestion and pressure
  • Warnings

    Ask a doctor before use if you have

    •
    heart disease
    •
    thyroid disease
    •
    diabetes
    •
    high blood pressure
    •
    trouble urinating due to an enlarged prostate gland

    When using this product

    •
    do not exceed recommended dosage
    •
    do not use this product 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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use.

    adults & children

    6 yrs. & older

    (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 24 hours.

    children 2 to under 6 yrs.

    ask a doctor

    children under 2 yrs.

    do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    TopCare® health

    COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT

    Sinus Nasal Spray

    SEVERE

    NASAL DECONGESTANT

    OXYMETAZOLINE HCl 0.05%

    WITH MENTHOL

    ULTRA FINE MIST

    12 HOUR RELIEF

    • Sinus Congestion & Pressure

    • Fast & Powerful Relief

    1 FL OZ (30 mL)

    sinus nasal spray-image
  • INGREDIENTS AND APPEARANCE
    TOPCARE SINUS NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-711
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-711-101 in 1 CARTON07/17/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/17/2018
    Labeler - Topco Associates LLC (006935977)
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