Label: NO DRIP NASAL MIST NASAL DECONGESTANT SEVERE CONGESTION- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    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 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 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

    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 rim between first and second fingers. Without tilting 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, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

    Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-991-30

    Compare to the active ingredient in Afrin® No-Drip Severe Congestion Pump Mist*

    NO DRIP

    NASAL MIST

    Nasal Decongestant

    Oxymetazoline HCl 0.05%

    SEVERE CONGESTION

    12 Hour Pump Mist

    Fast, Powerful Congestion Relief

    For Colds & Allergies

    Maximum Strength

    Unique Formula with Menthol

    1 FL OZ (30 mL)

    *This product is not manufactured and distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion Pump Mist.

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

    Satisfaction guaranteed or we’ll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    TAMPER EVIDENT: DO NOT USE IF SEAL OVER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

    No Drip Nasal Mist Nasal Decongestant Severe Congestion
  • INGREDIENTS AND APPEARANCE
    NO DRIP NASAL MIST NASAL DECONGESTANT SEVERE CONGESTION 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-991
    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, (-)- (UNII: 213N3S8275)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-991-301 in 1 CARTON08/21/2017
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/21/2017
    Labeler - Wal-Mart Stores,Inc., (051957769)
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