Arch Packaging Instant Gel Hand Sanitizer
FDA Label NDC 79847-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Arch Packaging Technologies Llc for the product Arch Packaging Instant Gel Hand Sanitizer (NDC 79847-001). 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 drug facts, active ingredient[s], purpose, use[s], warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient[S]
70% Ethanol by Volume
Purpose
Antiseptic
Use[S]
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 heat or flame.
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if 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
Carbopol (Thickener), Glycerin, Fragrance, Vitamin E, Tertiary Butyl Alcohol, Denatonium Benzoate, Diisopropylamine
Other
With Moisturizers and Vitamin E
Gentle Enough for Everyday Use
70% Ethyl Alcohol
DANGER: Highly Flammable liquid and vapor. Causes serious eye irritation. Keep container tightly closed. Keep out of reach of children. Keep away from heat/sparks/open flames/hot surfaces. No smoking. Use only non-sparking tools. Take precautionary measures against static discharge. May discolor certain fabrics or surfaces.
California SCAQMD Rule 443.1 VOC’S:
VOC: 70.50%
IN CASE OF FIRE: Use dry sand, dry chemical or alcohol-resistant foam to extinguish. Dispose of contents/container in accordance with local/regional/national/international regulations.
See SDS for Additional Information
Manufactured in St. Louis, MO
ARCH PACKAGING TECHNOLOGIES
10077 US HWY 61
Sainte Genevieve, MO 63670
www.archpackagingtechnologies.com
MADE IN USA
Packaging
Untitled (79847 001 2)
Untitled (79847001 3)
Untitled (79847 001)
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