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

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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)

FAQs

How many sprays of Oxymetazoline nasal spray should I take? ›

Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours. Children up to 6 years of age—Use and dose must be determined by your doctor.

What happens if you use too much Oxymetazoline hydrochloride? ›

Symptoms of overdose may include: drowsiness, slow heartbeat, dizziness, fainting. Do not share this medication with others.

Can I use oxymetazoline nasal spray every day? ›

If a nasal decongestant spray is a fixture in your medication lineup, it's important to know that using these sprays for more than three consecutive days can actually worsen your congestion. "This side effect of nasal decongestant sprays is called rebound congestion," says Dr.

What not to mix with oxymetazoline? ›

What Other Drugs Interact with Oxymetazoline Intranasal?
  • amitriptyline.
  • amoxapine.
  • azelastine.
  • clomipramine.
  • cromolyn sodium, intranasal.
  • desipramine.
  • doxepin.
  • imipramine.

Can you really only use nasal spray for 3 days? ›

If you use a medicated decongestant nasal spray for more than 3 days in a row, you may develop rebound rhinitis medicamentosa (RM) when you do stop. This condition can cause prolonged sinus congestion. It may even damage your nasal passages over time. RM can be quite uncomfortable.

Can you put too much nasal spray in your nose? ›

Rhinitis medicamentosa is a type of nasal congestion that occurs when you overuse nasal sprays. It causes irritation and inflammation in your nasal passages.

What if I accidentally swallowed Oxymetazoline nasal spray? ›

This medicine may cause harm if swallowed or if too much is used. The chance is higher in children. If Nasal Decongestant Spray (oxymetazoline (nasal)) is swallowed or too much is used, call a doctor or poison control center right away.

Is oxymetazoline bad for heart? ›

However, oxymetazoline is still a potent alpha‐1 adrenergic agonist and has the potential to cause systemic vasoconstriction and hypertension. This can cause myocardial oxygen supply/demand mismatch and can precipitate angina or myocardial infarction, especially in patients with impaired coronary circulation.

Does rebound congestion go away? ›

Rebound congestion is a severe stuffy nose. Rebound congestion develops when you use nasal sprays containing phenylephrine and oxymetazoline for too long. Rebound congestion is tough to treat and can take up to 1 year to go away. You can avoid rebound congestion by stopping decongestant nasal sprays after 3 to 5 days.

How long does Oxymetazoline nasal spray stay in your system? ›

Effects on α receptors from systemically absorbed oxymetazoline hydrochloride may persist for up to 7 hours after a single dose. The elimination half-life in humans is 5–8 hours.

Is oxymetazoline the same as Flonase? ›

Afrin (oxymetazoline) and Flonase (fluticasone propionate) are each nasal sprays that can provide a relief of symptoms related to nasal congestion. Though they are both nasal sprays, the mechanism by which they relieve congestion is very different.

What can I use instead of oxymetazoline? ›

Common decongestants include:
  • Afrin, Dristan, Vicks Sinex (oxymetazoline)
  • Sudafed PE (phenylephrine)
  • Silfedrine, Sudafed (pseudoephedrine)
Mar 25, 2023

Is oxymetazoline a steroid? ›

No, oxymetazoline (Afrin) isn't a steroid; it's a nasal decongestant, also known as alpha-1 agonist. If you have severe congestion, your primary care provider might recommend that you try both a steroid spray and oxymetazoline (Afrin).

Which is better, Afrin or Flonase? ›

One common misperception when choosing a nasal allergy spray is that all nasal sprays are created equal. However, this is not true. For example, nasal sprays such as Afrin® are only decongestants, while FLONASE allergy relief nasal sprays offer more complete* relief by treating additional nasal allergy symptoms.

How long does it take for rebound congestion to go away? ›

Generally, rebound congestion will last for as long as you continue to use the nasal decongestant spray. Usually, the congestion subsides within a week after discontinuing the use of the nasal spray. However, in some cases, rebound congestion can persist for several weeks or even months.

How long to wait to use oxymetazoline again? ›

Spray 2 or 3 times in each nostril, but not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

How long does oxymetazoline work for? ›

You can use up to 3 sprays of oxymetazoline (Afrin) every 10 or 12 hours. But don't use the medication for longer than 3 days. Doing so can worsen your congestion (rebound congestion) and make it harder to treat.

What is oxymetazoline 0.05 nasal spray for? ›

Adult: For the symptomatic relief of congestion associated with upper respiratory allergies, hay fever, common cold, sinusitis, and otitis media: As 0.05% nasal spray: Usual dose: 1-2 sprays into each nostril 2-3 times daily as necessary. Max treatment duration: 5-7 consecutive days.

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