COLOR ELEMENT ADVANCED HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- alcohol gel

Color Element Advanced Hand Sanitizer with Moisturizers and Vitamin E by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70% 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.

F lammable. 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 below 110 oF (43 oC) 
• May discolor certain fabrics or surfaces

Inactive Ingredients

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

​Package Labeling: 60 mL 74934-002-60

​Package Labeling: 100 mL 74934-002-10

​Package Labeling: 300 mL 74934-002-30

Package Labeling: 500 mL 74934-002-50

INGREDIENTS AND APPEARANCE

COLOR ELEMENT ADVANCED HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74934-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74934-002-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
2	NDC: 74934-002-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
3	NDC: 74934-002-30	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020
4	NDC: 74934-002-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/25/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang iColor Biotech Co., Ltd		554528308	manufacture(74934-002)