The Food and Drug Administration (FDA) warns the public from purchasing and using the following violative cosmetic products, which were detected to contain ACETALDEHYDE at levels above the acceptable limit, as reported in the ASEAN Post-Marketing Alert System (PMAS).
1. CUTICURA HAND SANITIZER
2. EPI KLLENGEL HAND SANITIZER GEL
3. GUARDIAN LAVENDER & PASSION FLOWER ANTIBACTERIAL HAND SANITISER
4. GUARDIAN ALOE & KOREAN-MINT ANTIBACTERIAL HAND SANITISER
5. KUNDAL FRESH WATER HAND SANITIZER+
6. SANITELLE® INSTANT HAND SANITIZER ANTISEPTIC GEL KIDS
7. CATH KIDSTON® MOISTURIZING HAND SANITISER
8. REDMOON BACTERIOSTAT WASH FREE HAND WASH GEL
9. COOL DAY’S PEPPERMINT INSTANT HAND SANITIZER
10. WALCH® INSTANT HAND SANITIZER
11. LIFEBUOY INSTANT HAND SANITIZER
12. FAIRPRICE HAND SANITISER LAVENDER
13. GERM-X ADVANCED HAND SANITIZER ORIGINAL SCENT
14. YURI® HAND GEL GREEN TEA EXTRACT
The aforementioned products have been tested by the Health Sciences Authority, Singapore, as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with acceptable technical standards.
The aforementioned products were verified to contain Acetaldehyde at levels above the acceptable limit. According to the U.S. Environment and Protection Agency (EPA), the primary acute effect of inhalation exposure to acetaldehyde is irritation of the eyes, skin, and respiratory tract in humans. At higher levels, erythema, coughing, pulmonary edema, and necrosis may also occur.
In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a health product is registered/notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.
All concerned establishments are warned not to distribute violative health products.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
To report any sale or distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at email@example.com, or call us at the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.