Otc - Active Ingredient
Ammonia (15%)
Summit Smelling Salts Inhalant
FDA Label NDC 85764-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Washburn Ventures Llc for the product Summit Smelling Salts (NDC 85764-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Inhalant
Indications & Usage
To prevent or treat fainting.
Warnings
WARNINGS: For external use only. Avoid contact with skin, eyes, and mouth.
Otc - Do Not Use
if allergic, pregnant or have respiratory conditions.
Otc - When Using
INSTRUCTIONS:
1.Shake well before use.
2.Unscrew cap and hold at least 6 inches from nose.
3. Inhale slowly no more than 1-2 times per use.
4.Seal tightly and store in a dark, dry place at room temperature.
BEFORE USE:
Remove plastic seal, unscrew cap, and remove foil from mouth of bottle. Reseal lid after each use.
POTENCY PRESERVATION :
To maintain potency over time, always seal the lid tightly immediately after each use. Before each session, shake the bottle thoroughly to ensure optimal ammonia activation. For best experience, store the bottle in a dark, dry place at room temperature.
Otc - Stop Use
STOP USE AND ASK A DOCTOR if symptoms occur.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. If ingested, seek medical attention or contact Poison Control immediately.
Dosage & Administration
DIRECTIONS: Hold bottle at least 6 inches from nose and inhale slowly no more than 1-2 times per use. Avoid repeated inhalationy
Storage And Handling
OTHER INFORMATION: Store at room temperature away from light and moisture.
Inactive Ingredient
Alcohol, Mint Flavor.
Package Label.Principal Display Panel
85764-001-01 (85764 001 01)
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