Otc - Active Ingredient
Ammonia (15%)
Allbizr Iron Shogun Smelling Salts Spray
FDA Label NDC 85209-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hong Kong Xile International Trading Limited for the product Allbizr Iron Shogun Smelling Salts (NDC 85209-011). 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, otc - keep out of reach of children, dosage & administration, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Inhalant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swallowed, getmedical 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 notinhale for more than 2 seconds per use,Do not use more than once every 60 minutes.Do not use more than 1l0 times per day.Use only as needed. lfsymptoms persist, consultahealthcare professional.
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 l5 minutes.Use only as directed. Misuse may be harmful.Use in a well-ventilated area. Do not use in enclosed
spacesProlonged exposure may cause irritation.Discontinue use if discomfort occurs.Possible side effects include nasal irritation, coughingor shortness of breath.lfsymptoms persist,discontinue use and consult a doctor.
Inactive Ingredient
Alcohol, Cotton, Peppermint Oil.
Package Label.Principal Display Panel
Labeling (85209 011 01)
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