Label: CVS HEALTH- nasal oxymetazoline hcl 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 September 13, 2023

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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    ▪
    for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    ▪
    temporarily relieves sinus congestion and pressure
    ▪
    shrinks swollen nasal 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 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 and prolonged use may cause nasal congestion to recur and to 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 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 within any 24-hour period.
    ▪
    children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
  • Other information

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

    benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol ,purified water, sodium phosphate dibasic, sodium phosphate monobasic.

  • Principal Display Panel

    CVS Health ™

    Compare to the active ingredient in Afrin® Original*

    NDC 69842-575-15

    Original

    Nasal Spray

    OXYMETAZOLINE HCl

    Nasal decongestant

    12 HOUR NASAL SPRAY

    Fast, Powerful Congestion Relief

    1/2 FL OZ (15 mL)

    DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Bayer Inc., the distributor of Afrin® Original

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive,

    Woonsocket, RI 02895

    © 2015 CVS/pharmacy

    CVS.com®

    1-800-SHOP CVS

    CVS Quality

    Money back Guarantee

    CVS Health Nasal Spray
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH 
    nasal oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-575
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-575-151 in 1 CARTON04/18/2019
    115 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 finalpart34104/18/2019
    Labeler - CVS Pharmacy,Inc. (062312574)
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