Label: CONGESTION RELIEF LIL DRUG STORE PRODUCTS- oxymetazoline hydrochloride spray

  • NDC Code(s): 66715-6860-4
  • Packager: Lil' Drug Store Products, Inc
  • 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 October 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline Hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • Temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies
    • Shrinks swollen nasal membranes so you can breathe more freely
  • 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 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 (1-800-222-1222) right away.

  • 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: consult 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° to 25°C (68° to 77°F)
    • retain carton for future reference on full labeling
  • Inactive ingredients

    benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate monobasic, sodium phosphate dibasic

  • Questions or comments

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Product distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    QUALITY

    ⋆GUARANTEED⋆

    Compare to the Active

    Ingredient in Afrin®*

    Original

    Nasal Spray

    Oxymetazoline HCl 0.05% Nasal Solution

    Nasal Decongestant

    Congestion Relief

    • Fast
    • Powerful
    • Long-lasting

    12 hour
    relief

    1 FL OZ

    (30 mL)

    Lil'

    Drug Store ®

    PDP/Package

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    CONGESTION RELIEF   LIL DRUG STORE PRODUCTS
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6860
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6860-41 in 1 CARTON12/15/2019
    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 finalpart34112/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)
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