Active Ingredient
Ethyl alcohol 62%
Hand Sanitizer
FDA Label NDC 73549-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fortress Expert Co., Ltd for the product Hand Sanitizer (NDC 73549-008). 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, purpose, uses, warnings, otc - do not use, otc - stop use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
Helps reduce bacteria that potentially can cause disease
Helps prevent cross contamination on contact
Recommended for repeated use
Warnings
Flammable, keep away from open flame and sources of heat
External use only
Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.
Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops
Keep out of reach of children
Otc - Do Not Use
Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops
Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, call a poison control center or get medical help right away .
Directions
Wet hands thoroughly with product and rub completely covering hands
·Allow to dry without wiping
·Children under the age of 6 should use with adult supervision
Not recommended for infants
Other Information
Store below 105F(41C)
May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance
PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)
Package Label Principal Display Panel
1 (30ml)
2 (60ml)
3 (237ml)
4 (1.8l)
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