Active Ingredient(S)
Ethanol 70%. Purpose: Antimicrobial
Hand Sanitizer
FDA Label NDC 80380-071
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shedrain Corporation for the product Hand Sanitizer (NDC 80380-071). 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 active ingredient(s), purpose, warnings, do not use, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hand sanitizer to help decrease bacteria on the skin.
Purpose (Purpose)
Warnings
Flammable. Keep away from fire or flame.
For external use only
Warning (Warning)
Do Not Use
Do not use in or near the eyes. If contact occurs, flush thoroughly with water.
Otc - Stop Use
Stop use and contact doctor if redness and irritation develops and persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.
Directions
Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.
Dosage & Admin (Dosage)
Other Information
Store below 110°F (43°C)
Inactive Ingredients
Aqua (Water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Animomethyl Propanol, Aloe Barbadensis Leaf Extract.
Indications & Usage
Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.
Indicate (Usage)
Package Label - Principal Display Panel
Instant Hand Sanitizer. 50mL
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