Otc - Active Ingredient
Ethyl Alcohol 62% v/v.....Antibacterial Agent
Ke-53ps Gel Hand Sanitizer
FDA Label NDC 64121-056
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kinzua Environmental, Inc. for the product Ke-53ps Gel Hand Sanitizer (NDC 64121-056). 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, inactive ingredient, otc - purpose, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Carbomer, Tocopheryl Acetate (Vitamin E), Aminomethyl Prpoanol
Otc - Purpose
For hand cleaning to decrease bacteria on skin.
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Do not use in the eyes. In case of contact, immediately flush with water.
Stop use and ask doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, contact a physician or poison center.
Dosage & Administration
To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.
Indications & Usage
For hand cleaning to decrease bacteria on skin.
Do not use in the eyes. In case of contact, immediately flush with water.
Stop use and ask doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, contact a physician or poison center.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison center.
Package Label.Principal Display Panel
64121-056-35.jpg (64121 056 35)
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