Active Ingredient
Ethyl Alcohol 80% v/v
Alcohol Hand Sanitizer
FDA Label NDC 75784-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tri-state Media, Llc for the product Alcohol Hand Sanitizer (NDC 75784-001). 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, purpose, uses, warnings, otc - do not use, 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
Purpose
Antiseptic
Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from source of heat, fire, or flame.
Otc - Do Not Use
Do not use in children less than 2 months of age. Do not use on open skin wounds.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
Children under 6 years should be supervised when using this product.
Other Information
Store at a temperature below 43C (110F).
May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Hydroxypropylcellulose (naturally derived), Glycerin, Isopropyl Myristate, Lauryl Lactate, Cetyl Lactate.
Package Label.Principal Display Panel
Alcohol
Hand Sanitizer
with
Premium Skin Conditioners and Moisturizers
Contains
Ethyl Alcohol 80%
PRD# 99000736
Lot# 0040205
Expiry 04/2022
Net Contents: 4L
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