Label: BEST CHOICE ALLERGY SINUS- oxymetazoline hydrochloride spray

  • NDC Code(s): 63941-721-30
  • 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 July 30, 2021

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:
    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. 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 tilting 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 proactive cap on tip.

  • Other information

    store at room temperature

    How to use:

     
    Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

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

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    Best Choice®

    NDC# 63941-721-30

    COMPARE TO ACTIVE INGREDIENT AFRIN® NO DRIP ALLERGY SINUS*

    12 HOUR NO-DRIP ALLERGY SINUS

    Nasal Mist

    OXYMETAZOLINE HCL 0.05%

    NASAL DECONGESTANT

    Fast and Powerful Congestion Relief Allergens

    1 FL OZ (30mL)

    Best Choice® 100% Guaranteed

    www.bestchoicebrand.com

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    BEST CHOICE

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

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

    Best Choice No-Drip Allergy Sinus Nasal Mist
  • INGREDIENTS AND APPEARANCE
    BEST CHOICE  ALLERGY SINUS
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-721
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.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:63941-721-301 in 1 CARTON05/22/2019
    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 finalpart34105/22/2019
    Labeler - BEST CHOICE (VALU MERCHANDISERS COMPANY) (868703513)