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Philippines FDA released the FDA Memorandum Circular 2020-001 to detail the labeling requirements for hand sanitizers.
According to the Circular, hand sanitizers shall be labeled with the following information:
Product name (a brand name is optional) e.g. 80% Ethyl Alcohol or 75% Isopropyl Alcohol
Function, e.g. antibacterial, antiseptic, sanitizing
Manufacturer's batch number
Manufacturing or expiry date or best before date
Country of manufacture
Net content
Direction for use
Special precautions
Full ingredient listing
Name and address of the company responsible for placing the product in the local market
Labeling of Hand Sanitizers for Health Care Personnel
The Philippines FDA has also introduced a labeling template for hand sanitizers for health care personnel use, shown below. The labeling information requirements have some subtle differences compared to the requirements for general hand sanitizers.
Active Ingredient Purpose |
Alcohol Antiseptic 80% or Isopropyl Alcohol 75% v/v………………………………....…………………………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 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 |
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 thus product to avoid swallowing. |
Other information • Store between 15-30C • Avoid freezing and excessive heat above 40C |
Inactive ingredients Glycerin, hydrogen peroxide, purified water USP |
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