Active Ingredients
Alcohol :62% v/v. Purpose: Antiseptic
Focan Llc Affex Care Hand Sanitizer(ac01-04-01)
FDA Label NDC 74913-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou S.e.z Baojie Industry Co., Ltd for the product Focan Llc Affex Care Hand Sanitizer(ac01-04-01) (NDC 74913-555). 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 ingredients, antiseptic, use, warnings, do note 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
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
For external use only. Flammable. Keep away from heat or flame
Do Note Use
In children less than 2 months of age. 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 throughly with water
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 swalloed get medical help or contact a poison control center right away
Direction
Place enought 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
Water, Peg-40 Castor oil, Carbomer ,sodium hydroxide ,Tocopherol
Package Label.Principal Display Panel
74913-500-01 (74913 500 01)
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