The following Structured Product Label (SPL) was submitted to the FDA by Vi-jon, Llc for the product Isopropyl Alcohol (NDC 0869-0804). 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, other safety information, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredientIsopropyl alcohol
Otc - Purpose
PurposeFirst aid antiseptic
Indications & Usage
Use first aid to prevent the risk of infection in:•minor cuts •scrapes •burns
Warnings
WarningsFor external use only
Flammable •keep away from fire or flame, heat, spark, electrical
For Rubbing + Massaging: Caution - Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes
Other information•does not contain, nor is intended as a substitute for grain or ethyl alcohol•will produce serious gastric disturbance if taken internally
Otc - Ask Doctor
Ask a doctor before use for deep wounds, animal bites or serious burns
Otc - When Using
When using this product •do not get into eyes •do not apply over large areas of the body •do not use longer than 1 week
Otc - Stop Use
Stop use and ask a doctor if condition persists or gets worse
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions •clean the affected area •apply 1 to 3 times daily
Inactive Ingredient
Inactive ingredient water
Adverse Reactions
Distributed by: Vi-JonOne Swan Drive, Smyrna, TN 37167
Package Label.Principal Display Panel
NDC 0869-0804-45Swan91%Isopropyl Alcohol•For treatment of minor cuts + abrasions•First Aid Antiseptic•Topical Antiseptic + Sanitizer•Preparation of Skin Prior to an InjectionSquare bottle use less plasticthan a similarly sized round bottleRecyclable (if available in your area)WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame32 FL OZ (1 QT) 946 mL
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