DailyMed - TOPCARE NASAL- oxymetazoline hydrochloride spray (2024)

  • Label RSS
  • NDC Code(s): 36800-304-10, 36800-304-72
  • 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 March 30, 2023

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

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  • Official Label (Printer Friendly)

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

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health

    COMPARE TO AFRIN® NASAL SPRAY ACTIVE INGREDIENT

    Nasal Spray

    NASAL DECONGESTANT

    OXYMETAZOLINE HCl 0.05%

    ORIGINAL

    12 HOUR RELIEF

    • Fast, Powerful Congestion Relief

    • For Colds & Allergies

    • Maximum Strength

    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:36800-304
    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, UNSPECIFIED FORM (UNII: GR686LBA74)
    EDETATE DISODIUM (UNII: 7FLD91C86K)
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
    WATER (UNII: 059QF0KO0R)
    Product Characteristics
    ColorWHITE (Translucent) Score
    ShapeSize
    FlavorImprint Code
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-304-101 in 1 CARTON12/15/1989
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:36800-304-721 in 1 CARTON03/17/200911/15/2017
    237 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 finalpart34112/15/1989

    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: 6

Published Date (What is this?) Version Files
Apr 6, 2023 7 (current) download
Nov 16, 2021 6 download
Dec 10, 2018 5 download
Mar 2, 2018 4 download
Oct 11, 2016 3 download
Dec 17, 2014 2 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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TOPCARE NASAL- oxymetazoline hydrochloride spray

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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 36800-304-10
2 36800-304-72
DailyMed - TOPCARE NASAL- oxymetazoline hydrochloride spray (2024)
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