Otc - Active Ingredient
Ammonia 15%
Allbiz Mint Oni Smelling Salts Inhalant
FDA Label NDC 85920-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Nanhai District Didi Didi E Commerce Co., Ltd. for the product Allbiz Mint Oni Smelling Salts (NDC 85920-003). 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 - keep out of reach of children, warnings, otc - purpose, dosage & administration, indications & usage, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Warnings
Do not ingest or apply to skin.
Avoid direct contact with eyes. If contact occurs, rinse thoroughly 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. If symptoms persist, discontinue use and consult a doctor.
Otc - Purpose
Inhalant For the temporary stimulation of the senses to restore alertness.
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. If symptoms persist, consult a healthcare professional.
Indications & Usage
Avoid contact with eyes, ears, and mouth.
If product gets into eyes, rinse thoroughly with water for 15 minutes.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Inactive Ingredient
Alcohol, Cotton, Peppermint Oil.
Other Safety Information
Store in a cool, dry place at 15-25°C (59-77°F).
Avoid freezing, excessive heat above 40°C (104°F), and direct sunlight.
Do not use if safety seal under cap is broken .
Package Label.Principal Display Panel
Labeling (85920 003 01)
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