Otc - Active Ingredient
Ammonia 2%
Smelling Salts Powder
FDA Label NDC 85765-002
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 85765-002). 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
For the temporarystimulation ofthe senses to restore alertness.
Warnings
For inHalAtion use only.
Avoid direct contact with eyes.lfcontact occurs,rinse thoroughly with water fori5 minutes.Use only as directed. Misuse may be harmful.
Use in a well-ventilated area.Do notuse in enclosedspaces
Prolonged exposure maycause irritation.Discantinue useifdiscomfort occurs.
Possible side effectsinclude nasallritation,coughing.or shortness of breath.lfsymptoms persist, discontinue use and consulta doctor
Otc - Do Not Use
Do not ingest or apply to skin.
Otc - When Using
Avoid contact with eyes,ears, and mouth.
Ifproduct gets into eyes, rinse thoroughly with water for 15minutes.
Stop use and ask a doctorifirritation orrash occurs.
These may be signs ofaserious condition.
Otc - Stop Use
Stop use and ask a doctorifirritation or rash occurs.
These may be signs ofa serious condition.
Otc - Keep Out Of Reach Of Children
Keep outofreach ofchildren.lfswallowed,get medical
help or contacta Poison control center immediately at 1-800-222-1222.
Inactive Ingredient
Alcohol
Cotton
Peppermint Oil
Package Label.Principal Display Panel
Label (Label)
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