Otc - Active Ingredient
alcohol 75% v/v purpose :antiseptic
alcohol 70% v/v purpose :antiseptic
alcohol 60% v/v purpose :antiseptic
Hand Sanitizer
FDA Label NDC 78623-370
9 label sections · Submitted to the FDA by Ningbo Fareast Industry Co.,ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Fareast Industry Co.,ltd for the product Hand Sanitizer (NDC 78623-370). 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 otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
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
. 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 thorough 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.
Otc - Stop Use
stop use and ask a doctor if irriation 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 posion control center right away
Dosage & Administration
place enough product on hands to cover all surface,rub hands together until dry
supervise children under 6 years when using this product to avoid swallowing
Package Label Principal Display Panel
75% alcohol concent
1000ml NDC: 78623-375-01
500ml NDC: 78623-375-02
237ml NDC: 78623-375-03
100ml NDC: 78623-375-04
60ml NDC: 78623-375-05
30ml NDC: 78623-375-06
70% alcohol concent
1000ml NDC: 78623-370-01
500ml NDC: 78623-370-02
237ml NDC: 78623-370-03
100ml NDC: 78623-370-04
60ml NDC: 78623-370-05
30ml NDC: 78623-370-06
60% alcohol concent
1000ml NDC: 78623-360-01
500ml NDC: 78623-360-02
237ml NDC: 78623-360-03
100ml NDC: 78623-360-04
60ml NDC: 78623-360-05
30ml NDC: 78623-360-06
* Please review the disclaimer below.
