Nasal Decongestant
FDA Label NDC 59970-052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies,llc for the product Nasal Decongestant (NDC 59970-052). 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, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
      • reduces swelling of nasal passages; shrinks swollen membranes
      • temporarily restores freer breathing through the nose

Warnings

Do not use this product for more than 3 days

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate

When Using This Product

  • do not exceed recommended dosage
  • use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop Use And Ask A Doctor If

symptoms persist

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • To spray, squeeze bottle qiuckly and firmly
  • Do not tilt head backward while spraying
  • Wipe nozzle clean after use
  • Do not exceed 2 doses in any 24 hour period
  • 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 to 12 hours
  • chlidren under 6 years of age: ask a doctor


Other Information

  • store at room temperature 15° - 30°C (59°-86°F)
    • retain carton for future reference on full labeling

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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