Label: CVS HEALTH ULTRA FINE MIST- oxymetazoline hydrochloride spray

  • NDC Code(s): 69842-726-16, 69842-726-30
  • Packager: CVS PHARMACY, 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 September 13, 2023

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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    temporarily relieves

    ▪
    nasal congestion due to a cold, heavy fever, or other upper respiratory allergies
    ▪
    Sinus congestion and pressure
  • Warnings

  • Ask a doctor before use if you have

    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    diabetes
    ▪
    thyroid disease
    ▪
    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 at (1-800-222-1222).

  • Directions

    ▪
    adults & children 6 years & 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 any 24-hour period.
    ▪
    Children 2 to under 6 years: ask a doctor
    ▪
    Children 2 years: do not use

    To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

  • Other information

    ▪
    store at room temperature
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    CVS Health™

    Compare to the active ingredient in Vicks® Sinex™ Severe Original*

    Ultra-Fine Mist

    12 HOUR

    Sinus Relief

    OXYMETAZOLINE HCl 0.05%

    Nasal decongestant

    FOR SINUS RELIEF

    •
    Fast acting day/night relief
    •
    Moisturizing
    •
    Cold & allergy congestion
    •
    Sinus pressure
    •
    Ultra fine pump mist

    Actual Bottle Size on Side Panel

    IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2019 CVS/pharmacy

    CVS.com

    1-800-SHOP CVS, V-12431

    ✓
    CVS Quality

    Money Back Guarantee

    Package contains One Bottle B

    *This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original.

    PACKAGE LABEL 15 mL

    cvs health Sinus relief

    Package Label Twin Pack 30 mL

    CVS Health Sinus Relief Twin Pack
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  ULTRA FINE MIST
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-726
    Route of AdministrationNASAL
    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 (NATURAL) (UNII: N20HL7Q941)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-726-161 in 1 CARTON03/12/2019
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:69842-726-302 in 1 CARTON03/12/2019
    215 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/12/2019
    Labeler - CVS PHARMACY, INC. (062312574)
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