Label: ZICAM INTENSE SINUS RELIEF- oxymetazoline hydrochloride spray

  • NDC Code(s): 10237-471-15
  • Packager: Church & Dwight Co., Inc.
  • 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 February 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
      • the common cold
      • hay fever
      • upper respiratory allergies
    • 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 result
    • 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.

  • Directions

    • adults and children 6 to under 12 years of age (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 any 24-hour period.
    • children under 6 years of age: ask a doctor

    To use pump:

    • to open, hold the actuator to squeeze and turn cap
    • hold with thumb at bottom of bottle and nozzle between fingers
    • before using the first time, prime pump by depressing several times
    • place tip of nozzle just past nasal opening (approximately 1/8")
    • pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
    • wipe nozzle clean after use
    • to close, turn cap until it 'clicks'
  • Other information

    • store between 15-29°C (59-84°F)
    • retain carton for future reference on full labeling
  • Inactive ingredients

    aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, menthol, monosodium phosphate, polysorbate 80, purified water

  • Questions? Comments?

    call 877-942-2626 toll free

    www.zicam.com

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    ZICAM®

    INTENSE
    SINUS
    RELIEF

    OXYMETAZOLINE HCl 0.05%
    NASAL DECONGESTANT

    12
    HOUR
    RELIEF

    COLDS*ALLERGIES

    Maximum Strength
    Relief of Sinus
    Pressure

    No-Drip Liquid®
    NASAL SPRAY

    Cooling
    Menthol & Eucalyptus

    0.50 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM INTENSE SINUS RELIEF 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-471
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-471-151 in 1 CARTON02/28/2022
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/28/2022
    Labeler - Church & Dwight Co., Inc. (001211952)
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