SPL v3
SPL
SPL Set ID 140e12a1-1e58-26d0-e063-6394a90ad88b
Route
NASAL
Published
Effective Date 2024-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (0.9 g)
Inactive Ingredients
Water Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-06-01

Description

Sodium Chloride 0.9%

Purpose

Nasal Moisturizer


Medication Information

Purpose

Nasal Moisturizer

Description

Sodium Chloride 0.9%

Uses
  • Restores vital moisture to provide prompt relief for dry, crusted, and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds, and other minor nasal irritations.
  • Helps remove inhaled irritants such as dust, dirt, and pollen.
Warnings
  • This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
  • The use of this dispenser by more than one person may spread infection.
  • Avoid spraying in eyes.
  • Content under pressure.
  • Do not puncture or incinerate.
  • Store between 59º and 86º F (15º and 30º C)
Directions

Read HOW TO USE instructions before use

  • Adults and children 4 years of age an older: Use as often as needed or as directed by a physician
  • Children under 4 years: Consult a physician.
Active Ingredient

Sodium Chloride 0.9%

Other Information

Do not use if the printed safety seal on the bottle is broken or missing.

Inactive Ingredients

Purified Water, Sodium Bicarbonate

Principal Display Panel


Structured Label Content

Uses
  • Restores vital moisture to provide prompt relief for dry, crusted, and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds, and other minor nasal irritations.
  • Helps remove inhaled irritants such as dust, dirt, and pollen.
Purpose

Nasal Moisturizer

Warnings
  • This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
  • The use of this dispenser by more than one person may spread infection.
  • Avoid spraying in eyes.
  • Content under pressure.
  • Do not puncture or incinerate.
  • Store between 59º and 86º F (15º and 30º C)
Directions

Read HOW TO USE instructions before use

  • Adults and children 4 years of age an older: Use as often as needed or as directed by a physician
  • Children under 4 years: Consult a physician.
Active Ingredient (Active ingredient)

Sodium Chloride 0.9%

Other Information (Other information)

Do not use if the printed safety seal on the bottle is broken or missing.

Inactive Ingredients (Inactive ingredients)

Purified Water, Sodium Bicarbonate

Principal Display Panel (Principal display panel)


Advanced Ingredient Data


Raw Label Data

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