COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 70 SOLUTION- alcohol liquid

COLOR ELEMENT Alcohol Antiseptic Hand Sanitizer 70 Solution by

Drug Labeling and Warnings

COLOR ELEMENT Alcohol Antiseptic Hand Sanitizer 70 Solution 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

Drug Facts

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

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 not use

• in children less than 2 months of age.
• on open skin wounds

When using this product

keep out of 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 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.

Directions

• Place enough 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 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, Glycerin, Sodium Hyaluronate, Tocopherol, Aloe Barbadensis Leaf Water

Package Labeling:

INGREDIENTS AND APPEARANCE

COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 70 SOLUTION 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74934-019
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)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74934-019-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020	01/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/11/2020	01/31/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang iColor Biotech Co., Ltd		554528308	manufacture(74934-019)