QUALITY CHOICE (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]

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QUALITY CHOICE (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-699-22
Set ID d01b8fb6-1ddf-4901-bda6-ae608e94a6a4
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    temporarily relieves nasal congestion due to:

    •
    a cold
    •
    hay fever
    •
    upper respiratory allergies
    •
    promotes nasal and sinus drainage
    •
    temporarily relieves sinus congestion and pressure
    •
    helps clear nasal passages; shrinks swollen nasal membranes
  • 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 (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 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 thump 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 protective cap on tip.

  • Other information

    •
    store at room temperature
    •
    retain carton for future reference on full labeling
  • 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

    NDC# 63868-699-22

    QUALITY CHOICE®

    *Compare to Active Ingredient in Mucinex® Full Force Nasal Spray

    12 Hour Relief

    Nasal Spray

    Nasal Decongestant

    Oxymetazoline HCl 0.05%

    Fast Relief of Sinus Pressure & Nasal Congestion

    3/4 FL OZ (22 mL)

    100% QC SATISFACTION GUARANTEED

    Distributed by C.D.M.A. Inc. ©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Full Force™ Nasal Spray.

    Quality Choice 12 Hours Relief Nasal Spray Oxymetazoline HCl
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-699
    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 (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-699-221 in 1 CARTON12/17/2018
    122 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 finalpart34112/17/2018
    Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)
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