Label: TOPCARE SINUS NASAL- oxymetazoline hydrochloride spray

  • 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 4, 2019

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

  • 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

    COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT

    Sinus Nasal Spray SEVERE

    NASAL DECONGESTANT

    OXYMETAZOLINE HCl 0.05%

    WITH MENTHOL

    ULTRA FINE MIST

    12 HOUR RELIEF

    OUR PHARMACISTS RECOMMEND

    Sinus Congestion & Pressure

    Fast & Powerful Relief

    1 FL OZ (30 mL)

    7x0-88-sinus-nasal-spray.jpg
  • 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 (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (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)