Otc - Active Ingredient
Ammonia 15%
Smelling Salts Granule
FDA Label NDC 85839-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Finona Information Technology Co., Ltd for the product Smelling Salts (NDC 85839-005). 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 - keep out of reach of children, dosage & administration, 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
For the temporary stimulation of the senses to restore alertness.
Warnings
For inhalation use only.
Do not ingest or apply to skin.
Avoid direct contact with eyes. lf contact occurs, rinsethoroughly with water for 15 minutes.
Use only as directed. Misuse may be harmful.
Use in a well-ventilated area. Do not use in enclosed spaces.
Prolonged exposure may cause irritation, Discontinue use if discomfort occurs.
Possible side effects include nasal irritation, coughing, or shortness of breath. lf symptoms persist, discontinue use and consult a doctor.
Otc - Do Not Use
It you have respiratory conditions such as asthma oremphysema.
If you have heart disease or high blood pressure.
If you are allergic to ammonia or strong odors.
Otc - When Using
Avoid contact with eyes, ears, and mouth.
lf product gets into eyes, rinse thoroughly with water for 15 minutes.
Stop use and ask a doctor ifirritation or rash occurs.
These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lfswallowed, get medical
help or contact a Poison Control centerimmediately at
1-800-222-1222
Dosage & Administration
Hold bottle 10-15 cm (4-6 inches) from nostrils.
Inhale gently. Do not place directly inside the nostrils.
Do not inhale for more than 2 seconds per use.
Do not use more than once every 60 minutes.
Do not use more than 10 times per day.
Use only as needed. lfsymptoms persist, consult ahealthcare professional
Inactive Ingredient
Alcohol
Cotton
Peppermint Oil
Package Label.Principal Display Panel
Label5 (Label5)
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