Active Ingredient
Sodium Chloride 0.9%
Saline Ampoules Spray
FDA Label NDC 69396-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Saline Ampoules (NDC 69396-116). 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, indications & usage, warnings, when using this product, keep out of the reach of children, if pregnant or breast feeding, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Moisturizer
Indications & Usage
This product may be used for conditions in the respiratory passages, nasal cavity or as directed by your healthcare provider.
Warnings
For External Use Only
Not for parenteral administration
When Using This Product
When using this product a mild and temporary irritation may be experienced at the beginning of use.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding
Ask a doctor before use.
Do Not Use
- Same applicator on more than one individual
- If sensitive to any of the components
Directions
For Adults and children 4 years and older. Use as often as needed.
Children under 4 years of age consult a doctor.
Hold vial gently and twist top off
Squeeze vial to dispense
Discard after use
Other Information
- Store at controlled room temperature 20°-25°C (68°-77°F) and protect from sunlight and sources of heat.
- See bottom of carton for Lot No. and Expiration data
- No Bacteriostatic or other preservatives added
Inactive Ingredients
Purified Water
Questions Or Comments
Call 1-888-296-9067
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