Xtreme Saline Rinse Mix Powder, For Solution
FDA Label NDC 74851-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xtreme Personal Care Inc for the product Xtreme Saline Rinse Mix (NDC 74851-010). 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, stop use and consult a health, 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
Active Ingredient
Sodium Bicarbonate 16.5 g
Sodium Chloride 49.5 g
Purpose
Nasal Wash
Uses
May relieve symptoms associated with
• allergies • post-nasal drip
• common cold • Nasal congestiom
Warnings
Stop Use And Consult A Health
care provider if washing is uncomfortable or symptoms not relieved or worsen after nasal rinsing, especially if fever, nosebleed, or headaches are present.
Keep Out Of Reach Of Children
Directions
- Use 1 packet per 200 ML as needed
| Adults and children 4 years and over: | Use 1-2 packets per 8 oz container every 2 hours as needed |
| Children under 4 years | Consult a physician |
Read Instructions for Use inside box for proper use
Other Information
- Inspect saline solution packets for integrity
- Do not use if open or torn
- Protect saline solution packet from excessive heat and moisture
Inactive Ingredients
None
Questions?
1-844-777-9601
Package Labeling:
Label0 (Label0)
Label02 (Label02)
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