Oxymetazoline Hydrochloride
FDA Label NDC 64762-864

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynamic Pharmaceuticals for the product Oxymetazoline Hydrochloride (NDC 64762-864). 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, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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, eucalyptol, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, potassium sorbate, purified water

Principal Display Panel - 15 Ml Carton

CVS®
pharmacy

Compare to the active
ingredient in Zicam®*

NEW!

Maximum
SINUS RELIEF
NO DRIP NASAL GEL
OXYMETAZOLINE HCl 0.05%

Quickly relieves sinus
pressure & nasal congestion

  • Long-lasting
  • Non-drowsy

    • 12
    Hour
    Relief

    Menthol Eucalyptus

    0.5 FL OZ (15mL)

    Principal Display Panel (15 mL Carton)

    Principal Display Panel (15 mL Carton)

* Please review the disclaimer below.