Active Ingredient
Sodium Chloride 0.65%
Saline Spray
FDA Label NDC 67777-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Saline (NDC 67777-310). 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, use(s), warnings, do not use, ask a doctor before use if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Restores Moisture
Use(S)
Moisturizes dry, irritated nasal passages due to:
• Colds • Dry air • Smoke • Air travel • Allergies
Warnings
• For Nasal use only
•The use of this dispenser by more than one person may spread infection.
Do Not Use
• In the eyes. If contact occurs flush with copious amounts of water
• For mouth dryness
Ask A Doctor Before Use If
You are pregnant or breast feeding.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Hold bottle upright and squeeze firmly for spray.
• Hold bottle upside down and squeeze gently for a drop.
• Use as often as needed or as directed by a physician.
• Wipe nozzle-tip clean after each use.
Other Information
• Store at room temperature between 15°-30°C (59°-86°F)
• Tamper evident. Do not use if seal is torn, cut, or opened.
Inactive Ingredients
Benzalkonium Chloride, Benzyl Alcohol, Disodium Phosphate, Sodium Phosphate Monobasic Anhydrous, Water
Questions?
1-888-396-2739 Monday - Friday 9AM - 5PM EST
Label
1410 Saline Nasal Spray
1411 Saline Nasal Spray
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