Label: OXYMETHAZOLINE HCL spray

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

Drug Label Information

Updated January 1, 2024

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

  • Drug Facts

  • Active ingredient

    Oxymetazoline HCL 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

  • ASK DOCTOR

    Ask a doctor before use if you have

    heart disease

    high blood pressure

    thyroid disease

    diabetes

    trouble urinating due to an enlarged prostate gland

  • STOP USE

    Stop use and ask a doctor if symptoms presist

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 10-12 hours. Do not exceed 2 doeses in 24 hours.

    children under 6 years of age: ask a doctor.

    Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.

  • Other information

    store between 20º to 25º C (68º to 77º F)

    retain carton for future referance on full labeling

  • Inactive ingredients

    benzalkoium cjloride, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • 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 prduct

    do not use more than directed

    do not use 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, sneexing, or an increased nasal discharge may occur

    use of this container by more than one person may spread infection

  • PRINCIPAL DISPLAY PANEL

    NDC 71205-383-30

    Reliabel-1 Laboratories

    12 Hour Decongestant Nasal Spray

    Oxymetazoline HCL

    Pump Mist Anti-Drip

    Rapid & Powerful

    Congestion Relief

    12 Hour Relief

    1 FL OZ (30 mL)

    71205-383-30
  • INGREDIENTS AND APPEARANCE
    OXYMETHAZOLINE HCL 
    oxymethazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-383(NDC:69618-050)
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-383-301 in 1 CARTON01/10/2019
    11 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2019
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-383) , RELABEL(71205-383)