Color Element Alcohol Free Hand Sanitizer

Color Element Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Color Element Alcohol Free 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]

COLOR ELEMENT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid 
Zhejiang iColor Biotech Co., Ltd

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Color Element Alcohol Free Hand Sanitizer

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

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

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.

Inactive ingredients

Water, Propylene Glycol, Polyquaternium-37,Didecyldimonium Chloride,Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, Fragrance, Phenoxyethanol.

Package Labeling:30ml

Box4

Package Labeling:2ml

Bottle

COLOR ELEMENT ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74934-048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74934-048-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202001/31/2026
2NDC: 74934-048-022 mL in 1 BAG; Type 0: Not a Combination Product09/07/202001/31/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)09/07/202001/31/2026
Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)

Revised: 1/2024
Document Id: 0fb3b0d8-393b-a274-e063-6394a90aa3a5
Set id: ee223389-0a31-40bd-bca9-978283db5994
Version: 3
Effective Time: 20240124