Otc - Active Ingredient
Ammonia 15%
Smelling Salts Inhalant
FDA Label NDC 85821-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Weikeduo E-commerce Co., Ltd. for the product Smelling Salts (NDC 85821-001). 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
Inhalants
Indications & Usage
To prevent or treat fainang.
Warnings
For external use only.
Otc - Do Not Use
Do not use if you have respiratory conditions such as asthma or emphysema. Discontinue use and consult a doctor if symptoms persist
Otc - When Using
Avoid repeated inhalation. Do not use more than 2 times per application.
Otc - Stop Use
Stop use and ask a doctor if allergic reaction (rash, swelling) or persistent irritation occurs.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN: Store in a cool, dry place inaccessible to children. Swallowing may cause poisoning. If swallowed, seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222).
Dosage & Administration
Hold bottle 10-15 cm from nostrils and inhale slowly 1-2 times.
Storage And Handling
Store in a cool, dry place inaccessible to children.
Inactive Ingredient
Alcohol, Cotton, Peppermint Flavour
Package Label.Principal Display Panel
85821-001-01 (85821 001 01)
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