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Drug Facts
Instant Antiseptic Hand Sanitizer Solution
FDA Label NDC 63998-364
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Laboratories Inc. for the product Instant Antiseptic Hand Sanitizer (NDC 63998-364). 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 other, active ingredient, purpose, uses, warnings, 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
Active Ingredient
Ethyl Alcohol 70%v/v
Purpose
Sanitizer
Uses
For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.
Warnings
Flammable. Keep away from fire or flame.
For external use only
Otc - When Using
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
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.
Directions
Apply gel to dry hands and rub thoroughly until hands are dry. Do not rinse or wipe gel off. Should solution enter eyes, rinse immediately with water.
Other Information
Store below 110°F (43°C). May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Propylene Glycol, PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Triethanolamine, Carbopol and Fragrance.
Principal Display Panel - 750 Ml Bottle Label
UNITED
LABORATORIES
United 364
CONTACT PLUS
Instant Antiseptic
Hand Sanitizer
Kills 99.99% of common germs that can cause
disease. Evaporates quickly.
750 ml (25 fl. oz.)
Made in USA 1018
Principal Display Panel (750 ml Bottle Label)
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