Oxymetazoline Hydrochloride Spray
FDA Label NDC 63868-607

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 63868-607). 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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information

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

Inactive Ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate monobasic, sodium phosphate dibasic

Principal Display Panel

NDC-63868-607-01

Containerlabel607 (Containerlabel607)

Containerlabel607 (Containerlabel607)

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