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  5. Label Information: Winco Foods Extra Moisturizing Nasal Relief

FDA Label for Winco Foods Extra Moisturizing Nasal Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winco Foods Extra Moisturizing Nasal Relief Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, 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.

Otc - Active Ingredient



Active Ingredient                                                                                                          Purpose

Oxymetazoline HCI 0.05%-----------------------------------------------------------------------  Nasal decongestant


Otc - Purpose



Uses

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

Warnings



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

Otc - When Using



When using this product

  • do not use more than directed
  • do not use more than 3 days. 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

Otc - Stop Use



Stop use and ask a doctor if symptoms persist


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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.


Indications & Usage



Direction

  • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more 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
  • Shake well before use.  To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after each use and snap cap back onto the bottle.

Storage And Handling



Other information

  • Store between 20° and 25°C (68° and 77°F)
  • Retain carton for future reference on fully labeling

Inactive Ingredient



Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, glycerin, monobasic sodium phosphate dihydrate, polyethylene glycol 1450, polyvinylpyrrolidone K30, purified water


Dosage & Administration



DISTRIBUTED BY:

WINCO FODDS, LLC,

BOISE, ID 83704

MADE IN KOREA


Package Label.Principal Display Panel



image description - 24108

image description - 24108


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