COLOR ELEMENT ADVANCED HAND SANITIZER- alcohol gel

Color Element Advanced Hand Sanitizer by

Drug Labeling and Warnings

Color Element Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang iColor Biotech Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.

Warnings

For external use only

Flammable. Keep away from heat or flame

When using this product

do not use in or near 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 appears on the skin.

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.
• Children under 6 years of age should be supervised by adult when applying this product.
• Do not use on children less than 2 months of age or on open skin wounds.

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
• May discolor some fabrics or surfaces

Inactive ingredients

Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, AMinomethyl Propanol.

Package Labeling:

INGREDIENTS AND APPEARANCE

COLOR ELEMENT ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74934-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
PANTHENOL (UNII: WV9CM0O67Z)
INULIN (UNII: JOS53KRJ01)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FRUCTOSE (UNII: 6YSS42VSEV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74934-003-38	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/07/2020

Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang iColor Biotech Co., Ltd		554528308	manufacture(74934-003)