140e12a1-1e58-26d0-e063-6394a90ad88b

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

Purpose

Nasal Moisturizer

Description

Sodium Chloride 0.9%


Medication Information

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)
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

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.
Other Information

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

Inactive Ingredients

Purified Water, Sodium Bicarbonate

Description

Sodium Chloride 0.9%

Principal Display Panel

Active Ingredient

Sodium Chloride 0.9%


Structured Label Content

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)
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

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.
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)

Active Ingredient (Active ingredient)

Sodium Chloride 0.9%


Advanced Ingredient Data


Raw Label Data

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