Color Element Antibacterial wipes

Color Element Antibacterial wipes by

Drug Labeling and Warnings

Color Element Antibacterial wipes 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 ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
Zhejiang iColor Biotech Co., Ltd

----------

Color Element Antibacterial wipes

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

  • Hand sanitizer to help reduce bacteria on the skin

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

  • wet hands thoroughly with product and allow to dry.
  • Discard wipes in trash receptacle after use. Do not flush.
  • Children under 6 years of age should be supervised by adult when applying this product.

Inactive ingredients

Water, Propylene Glycol, Didecyldimonium Cholride, Polyaminopropyl Biguanide, Aloe Barbadensis Leaf Water, phenoxyethanol, Edetate Disodium Anhydrous, Citric Acid, Sodium citrate, Dimethicone

Questions or Comments?

212-551-2657

Package Labeling:

Label2

COLOR ELEMENT ANTIBACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74934-043
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74934-043-0170 in 1 CANISTER08/05/202001/31/2026
13.64 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/05/202001/31/2026
Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)

Revised: 1/2024
Document Id: 0fb24cd8-f693-1285-e063-6394a90a1458
Set id: 4f9f208e-e483-4b5f-9ce7-eab3b7bf66fe
Version: 2
Effective Time: 20240124