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  5. Label Information: Oxymetazoline Hydrochloride

FDA Label for Oxymetazoline Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL - 15 ML CARTON

Oxymetazoline Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Dynamic Pharmaceuticals. 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
  • helps clear nasal passages
  • shrinks swollen membranes
  • temporarily relieves sinus congestion and pressure

Warnings



For nasal use only.


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 result
  • use of this container by more than one person may spread infection

Directions



  • adults and children 6-12 years of age (with adult supervision): Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use.
  • Do not use more often than once every 10 to 12 hours.
  • Do not exceed 2 doses in any 24 hour period.
  • Children under 6 years of age: consult a doctor

    • To use pump:

    • Remove cap and safety clip.
    • Hold with thumb at bottom of bottle and nozzle between fingers.
    • Before using the first time, prime pump by depressing several times.

Other Information



  • Retain carton for future reference on full labeling
  • Remove lock ring before each use

Inactive Ingredients



aloe barbadensis gel, d-alpha-tocopherol-ester, disodium EDTA, disodium phosphate, ethylene & propylene oxide copolymer, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, potassium sorbate, purified water


Principal Display Panel - 15 Ml Carton



CVS®
pharmacy

Compare to the active
ingredient in Zicam®*

NEW!

Maximum
CONGESTION
RELIEF
NO DRIP NASAL GEL
OXYMETAZOLINE HCl 0.05%

Quickly relieves nasal
congestion & sinus pressure

* Please review the disclaimer below.