Label: DRISTAN 12 HR- oxymetazoline hydrochloride spray

  • NDC Code(s): 80070-400-05
  • Packager: Foundation Consumer Brands
  • 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 August 9, 2021

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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 a cold, hay fever or other upper respiratory allergies
    • shrinks swollen membranes
    • temporarily restores freer breathing through the nose
    • temporarily relieves sinus congestion and pressure
  • 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
    • may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
    • the 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.

  • Directions

    • adults and children 6 to under 12 years of age (with adult supervision): 2 to 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 To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.
  • Other information

    • store at 20-25°C (68-77°F)
    • container is filled to proper level for correct spray action
    • retain carton for full labeling
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

  • Questions or comments?

    Call 1-888-594-0710 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Foundation Consumer Brands, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Dristan®
    12
    HOUR
    NASAL
    SPRAY

    Oxymetazoline HCl 0.05%
    Nasal Decongestant

    Fast Acting Relief
    Sinus & Nasal
    Congestion

    Relieves:

    ✓
    Sinus Congestion & Pressure
    ✓
    Nasal Congestion due to
    Colds & Allergies
    ✓
    Swelling of Nasal Passages

    0.5 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DRISTAN   12 HR
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-400
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorYELLOW (clear, colorless to slightly yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80070-400-051 in 1 CARTON08/17/2021
    115 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 FINALpart34108/17/2021
    Labeler - Foundation Consumer Brands (117603632)
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