Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Alcohol Hand Sanitizer
FDA Label NDC 78792-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Theaoson Technology Co.,ltd for the product Alcohol Hand Sanitizer (NDC 78792-012). 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
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Keep away from the source of fire and flame. For external use only.
Do Not Use
in children less than 2 months of age
on open skin wounds, damaged, inflamed or broken skin.
Otc - When Using
When using this product, keep out of eyes, ears, and mouth. Use only under adult supervision. In case of contact with eyes, rinse eyes thoroughly with water.
Non staining, may discolor certain fabrics. People who are allergic to alchohol shuld use this product with caution.
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.
Otc - Stop Use
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
acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, water
Package Label - Principal Display Panel
78792-012-01 50ML
78792-012-02 100ML
78792-012-03 182ML
78792-012-04 478ML
78792-012-05 494ML
78792-012-06 1000ML
78792-012-07 5000ML
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