Label: OXYMETAZOLINE HYDROCHLORIDE 12-HOUR- oxymetazoline hydrochloride spray

  • NDC Code(s): 51672-2030-3, 51672-2030-5
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL

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 January 15, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • temporary relief of nasal congestion
      • due to the common cold
      • due to hay fever or other upper respiratory allergies
      • associated with sinusitis
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not exceed recommended dosage

    This product 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.

    Do not use

    • for more than 3 days

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    • frequent or prolonged use may cause nasal congestion to recur or worsen

    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 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 the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
  • Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    Compare to the
    active ingredient
    in Afrin ®*

    Nasal
    Decongestant
    12- Hour Spray

    Oxymetazoline
    Hydrochloride 0.05%

    Maximum Strength

    • Fast Acting
    • Up To 12 Hours Relief

    Contains the Active Ingredient
    Recommended Most by
    Physicians and Pharmacists

    12

    1 fl oz (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HYDROCHLORIDE   12-HOUR
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2030
    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)  
    sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
    polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2030-51 in 1 CARTON02/25/2006
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:51672-2030-31 in 1 CARTON02/25/2006
    230 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 FINALpart34102/25/2006
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220MANUFACTURE(51672-2030)
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