DailyMed - TOPCARE NASAL- oxymetazoline hydrochloride spray (2024)

  • Label RSS
  • NDC Code(s): 36800-817-10
  • Packager: Topco Associates LLC
  • 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 November 28, 2018

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

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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose
  • Uses
    temporarily relieves nasal congestion due to:
    common cold
    hay fever
    upper respiratory allergies
    temporarily relieves sinus congestion and pressure
    shrinks swollen nasal membranes so you can breathe more freely
  • 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

    To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

  • Other information
    store at 20-25°C (68-77°F)
    retain carton for future reference on full labeling
  • Inactive ingredients

    benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, monobasic sodium phosphate, polysorbate 80, propylene glycol, purified water

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    COMPARE TO AFRIN® ALLERGY SINUS NASAL SPRAY ACTIVE INGREDIENT

    Nasal Spray

    NASAL DECONGESTANT OXYMETAZOLINE HCl 0.05%

    ALLERGY SINUS

    12 HOUR RELIEF

    OUR PHARMACISTS RECOMMEND

    Fast, Powerful Congestion Relief from Allergies

    Reduces Swelling of Nasal Passages

    1 FL OZ (30 mL)

    DailyMed - TOPCARE NASAL- oxymetazoline hydrochloride spray (2)

  • INGREDIENTS AND APPEARANCE
    TOPCARE NASAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-817
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05g in100mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
    BENZYL ALCOHOL (UNII: LKG8494WBH)
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
    EDETATE DISODIUM (UNII: 7FLD91C86K)
    EUCALYPTOL (UNII: RV6J6604TK)
    MENTHOL (UNII: L7T10EIP3A)
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
    WATER (UNII: 059QF0KO0R)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-817-101 in 1 CARTON08/06/1996
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/06/1996

    Labeler -Topco Associates LLC(006935977)

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More Info on this Drug

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TOPCARE NASAL- oxymetazoline hydrochloride spray

Number of versions: 5

Published Date (What is this?) Version Files
Nov 30, 2018 5 (current) download
May 7, 2018 4 download
Sep 6, 2016 3 download
Jan 7, 2015 2 download
Oct 9, 2010 1 download

RxNorm

TOPCARE NASAL- oxymetazoline hydrochloride spray

RxCUI RxNorm NAME RxTTY
1 1000990 oxymetazoline HCl 0.05 % Nasal Spray PSN
2 1000990 oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray SCD
3 1000990 oxymetazoline hydrochloride 0.05 % Nasal Spray SY

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NDC Codes

TOPCARE NASAL- oxymetazoline hydrochloride spray

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 36800-817-10
DailyMed - TOPCARE NASAL- oxymetazoline hydrochloride spray (2024)
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