Topco Associates Llc. Nasal Spray Drug Facts

Topco Associates Llc. Nasal Spray Drug Facts
SPL v9
SPL
SPL Set ID f2b2467f-2d9b-4742-b90a-95975c3b694f
Route
NASAL
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Sodium Phosphate, Monobasic, Unspecified Form Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-12-15 Until 2017-11-15

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline hydrochloride 0.05%

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
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.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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)

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).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

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
Purpose

Nasal decongestant

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.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

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

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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