Leader Nasal Decongestant Spray
FDA Label NDC 70000-0665

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110,inc for the product Leader Nasal Decongestant (NDC 70000-0665). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Oxymetazoline 0.05%

Purpose

Nasal Decongestant 

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely

Warnings

Ask a Doctor before use if you have

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

When Using This Product

Do not use more than directed

  • do not use for more than three 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 occur.
  • use of this container by more than one person may spread infection.

    • Stop use and ask a Doctor if symptoms persist

Keep Out Of The Reach Of Children

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

Directions

  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.

Other Information

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

Inactive Ingredient

Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Display Panel 1 Floz

Leader          NDC 70000-0665-1

12 Hour ND Nasal Decongstant

Oxymetazoline HCL 0.05% 

Nasal Decongestant 

1 FLOZ (30ml)

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