Active Ingredient(S)
Ethyl Alcohol 70.0%V/v
Hand Sanitizer
FDA Label NDC 58503-804
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetic Technology Corp. for the product Hand Sanitizer (NDC 58503-804). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not avaliable.
Warnings
For extemal use only. Flammable, Keep away from heat or flame
Do Not Use
● on infants
● on open skin wounds
Otc - When Using
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 lf irritation or rash occurs. these may be signs of a serious condition.
Otc - Stop Use
Stop use and ask a doctor lf 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
● Apply as needed into palm of hand and thoroughly spread on both hands, rub until dry.
● Supervise children under 6 years of age when using thisproduct.
Other Information
● Store between15-30°c(59-86°F)
● Avoid freezing and excessive heat above40°c(104°F)
Inactive Ingredients
Deionized water, Triethanolamine, Carbomer,Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocophe Acetate
Package Label - Principal Display Panel
3 (3)
2 (2)
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