Active Ingredient
ALCOHOL 62% v/v
New Clean Hand Sanitizer
FDA Label NDC 78023-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by U2 for the product New Clean Hand Sanitizer (NDC 78023-010). 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, inactive ingredient, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Triethanolamine, Polysorbate 20, Glycerin, Carbomer, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Fragrance
Purpose
Antiseptic
Warnings
Warnings:
For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
■ instant hand antiseptic to decrease bacteria on the skin
■ recommended for repeated use
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 1~30℃
■ Avoid freezing and excessive heat above 40℃ (104F)
Questions?
■ +82-10-2863-2511 (Mon. to Fri. 10 AM-5 PM)
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