Otc - Active Ingredient
Active ingredient Purpose
Sodium Chloride 0.65%......................Moisturizer
Family Care Saline Spray
FDA Label NDC 65923-493
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Saline (NDC 65923-493). 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 otc - active ingredient, otc - purpose, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
temporary relief of dry, irritated nasal passages due to colds, flu, allergies, pollution, and the use of decongestants/steroidal sprays
Warnings
Warnings
For external use only
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- holding bottle upright for spray, horizontally for stream, and upside down for drop applications
- adults and children under 6 years of age: squeeze twice in each nostril as needed
- children under 6 years of age: consult a doctor
- using this dispenser by more than one person may spread infection
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
- do not use if printed seal around the cap is broken or missing
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate
Dosage & Administration
Distributed by: United Exchange Corp.
Cypress, CA 90630 USA
Made in China
Package Label.Principal Display Panel
493 (493.1)
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