Otc - Active Ingredient
Ethyl Alcohol 62% v/v.....Antibacterial Agent
Instant Hand Sanitizer (gel-type)
FDA Label NDC 53341-056
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tranzonic Companies for the product Instant Hand Sanitizer (gel-type) (NDC 53341-056). 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 Propanol
Otc - Purpose
For hand cleaning to decrease bacteria on skin that could cause disease. Recommended for repeated use.
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 a 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.
Children under 6 years of age should be supervised when using this product.
Indications & Usage
For hand cleaning to decrease bacteria on skin that could cause disease.
Do not use in the eyes. In case of contact, immediately flush with water.
Stop use and ask a 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
53341-056-27.jpg (53341 056 27)
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