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  5. Label Information: Oxymetazoline Hydrochloride

FDA Label for Oxymetazoline Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT                         PURPOSE
    2. USES
    3. DIRECTIONS
    4. OTHER INFORMATION
    5. INACTIVE INGREDIENTS
    6. PRINCIPAL DISPLAY PANEL

Oxymetazoline Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc.. 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                         Purpose



Oxymetazoline HCl 0.05%............. Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • 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 10-12 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 and tum in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tiltlng the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.

Other Information



  • store between 20˚C to 25˚C (68˚F to 77˚F)
  • retain carton for future reference on full labeling

Inactive Ingredients



  • No Drip Original Nasal Pump Mist- (NDC-63868-605-01) avicel. benzalkonium chloride, benzyl alcohol. dibasic sodium phosphate, edetate disodium dihydrate, flavor, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
  • No Drip Extra Moisturizing Nasal Pump Mist- (NDC-63868-676-01) avicel. benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Principal Display Panel



NDC-63868-605-01

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NDC-63868-676-01


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