Otc - Active Ingredient
Active Ingredient Purpose
Ethyl Alcohol 62.0%......................Antimicrobial
Instant Hand Sanitizer
FDA Label NDC 64092-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Great Lakes Wholesale & Marketing, Llc for the product Instant Hand Sanitizer (NDC 64092-318). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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
Otc - Purpose
XtraCare Instant Hand Sanitizer - Original
Kills 99.9% of Germs with Moisturizers & Vitamin E
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.
Indications & Usage
USE:
- hand sanitizer to help reduce bacteria on the skin that may cause disease
Warnings
Warnings:
for external use only.
Flammable. Keep away from heat and flame.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
Dosage & Administration
Directions:
- wet hands thoroughly with product
- briskly rub hands together until dry
- children under 6 years of age should be supervised by an adult when using.
Inactive Ingredient
Inactive ingredients:
carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.
Package Label.Principal Display Panel
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