Summit Smelling Salts
36b6ed08-4a98-6b31-e063-6394a90a6fb7
HUMAN OTC DRUG LABEL
Jun 9, 2025
Washburn Ventures LLC
DUNS: 136693055
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Summit Smelling Salts
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
To prevent or treat fainting.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
OTHER INFORMATION: Store at room temperature away from light and moisture.
INACTIVE INGREDIENT SECTION
Alcohol, Mint Flavor.
OTC - ACTIVE INGREDIENT SECTION
Ammonia (15%)
OTC - PURPOSE SECTION
Inhalant
WARNINGS SECTION
WARNINGS: For external use only. Avoid contact with skin, eyes, and mouth.
OTC - DO NOT USE SECTION
if allergic, pregnant or have respiratory conditions.
OTC - WHEN USING SECTION
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 SECTION
STOP USE AND ASK A DOCTOR if symptoms occur.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. If ingested, seek medical attention or contact Poison Control immediately.