Label: BEST CHOICE ULTRA FINE MIST- oxymetazoline hydrochloride spray

  • NDC Code(s): 63941-726-30
  • Packager: BEST CHOICE (VALU MERCHANDISERS COMPANY)
  • 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 June 22, 2022

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

  • 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: ask a doctor

    Shake well before use. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

  • 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

    Best Choice®

    NDC# 63941-726-30

    COMPARE TO THE ACTIVE INGREDIENT IN VICKS® SINEX®*

    12 HOUR SINUS RELIEF

    OXYMETAZOLINE HCl 0.05%

    NASAL DECONGESTANT

    Ultra-Fine Mist For Sinus Relief

    Cold & allergy congestion
    Sinus pressure

    1 FL OZ (30 mL)

    IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING

    Best Choice® 100% Guaranteed

    www.bestchoicebrand.com

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

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

    Best Choice Sinus Relief
  • INGREDIENTS AND APPEARANCE
    BEST CHOICE  ULTRA FINE MIST
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-726
    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:63941-726-301 in 1 CARTON05/21/2019
    130 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 finalpart34105/21/2019
    Labeler - BEST CHOICE (VALU MERCHANDISERS COMPANY) (868703513)