Active Ingredient
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Gel Hand Sanitizer
FDA Label NDC 75396-315
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Buckairways Inc. for the product Gel Hand Sanitizer (NDC 75396-315). 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, 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; Hand Sanitizer
Uses
To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.
Warnings
For external use only: Hands. Flammable, keep aware from fire or flame.
Do Not Use
In children less than 2 months of age. On open skin or wounds.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor ir irritation or rash occurs. These may be signs of a serious condition.
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
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence
Packaging Label - Principal Display Panel
59 ML NDC Code 75396-315-17
FRONT
BACK
118ML NDC Code 75396-315-18
FRONT
BACK
3785ML NDC Code 75396-315-19
FRONT
BACK
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