Oxymetazoline Hydrochloride Spray
FDA Label NDC 63868-676

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Oxymetazoline Hydrochloride (NDC 63868-676). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                         purpose, uses, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Containerlabel605 (Containerlabel605)

Containerlabel605 (Containerlabel605)

NDC-63868-676-01

Containerlabel676 (Containerlabel676)

Containerlabel676 (Containerlabel676)

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