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  5. Label Information: Topcare Nasal

FDA Label for Topcare Nasal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Topcare Nasal Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Oxymetazoline hydrochloride 0.05%


Purpose



Nasal decongestant


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

Ask A Doctor Before Use If You Have



  • •heart disease
  • •high blood pressure
  • •diabetes
  • •thyroid disease
  • •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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.


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, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water


Questions Or Comments?



1-888-423-0139


Principal Display Panel



EXTRA MOISTURIZING

Nasal Spray

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12 Hour Relief

Fast, powerful congestion relief

Soothes and helps rehydrate dry noses

For colds & allergies

COMPARE TO AFRIN® NASAL SPRAY active ingredient

1 FL OZ (30 mL)


* Please review the disclaimer below.