Active Ingredient(S)
Ethyl alcohol 75% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 76390-0108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Soap Co., Ltd. for the product Hand Sanitizer (NDC 76390-0108). 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, otc - 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
Antiseptic
Use
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.
Otc - Do Not Use
- Do not use on children less than 2 months of age
- Do not use on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth.
If case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs.
Thess may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 59-86 ℉ (15-30 ℃).
Avoid freezing and excessive heat above 104 ℉ (40 ℃).
Inactive Ingredients
Water (Aqua), Acrylates/C10-30 Alkyl/Acrylate Crosspolymer, Triethanolamine, Glycerin, Aloe Extract, Panthenol (pro-Vitamin B5)
Package Label - Principal Display Panel
500 (500)
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