Otc - Active Ingredient
Ammonia 2%
Smelling Salts Inhalant
FDA Label NDC 85765-003
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 Ze'ai Electronic Co., Ltd. for the product Smelling Salts (NDC 85765-003). 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
Forthe temporarystimulation of the senses to restore alertness
Warnings
ForinHalAtion use only.
Do notingest or apply to skin.
Avoid direct contact with eyes. lfcontact occurs, rinse thoroughly with water for l5 minutes.
Use only as directed. Misuse may be harmful.
Use in a well-ventilated area. Donot usein enclosed spaces.
Prolonged exposure may cause irritation. Discontinue use if discomfort occurs.
Possible side effectsinclude nasaliritation, coughing, or shortness of breath.lf symptoms persist, discontinue use and consult a doctor.
Otc - Do Not Use
lf you have respiratory conditions such as asthma oremphysemA.
lf you have heart disease or high blood pressure.
lf you are allergic to ammonia or strongodors.
Otc - When Using
Avoid contact with eyes,ears, and mouth.
lf product gets into eyes, rinse thoroughly with water for 15minutes.
Stop use and ask a doctor ifirritation or rash occurs.
These may be signs of a serious condition.
Otc - Stop Use
Stop use and ask a doctorifirritation orrash occursThese may be signs of a serious condition,
Otc - Keep Out Of Reach Of Children
Keep out ofreach ofchildren.lfswallowed, get medical
help or contacta 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 directlyinside the nostrils.
Do notinhale 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 a healthcare professional.
Inactive Ingredient
Alcohol
Cotton
Peppermint Oil
Package Label.Principal Display Panel
Label (Label)
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