Label: COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 75- alcohol liquid

  • NDC Code(s): 74934-034-01
  • Packager: Zhejiang iColor Biotech Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 75% v/v

    Purpose

    Antiseptic

  • Uses

    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

    Purified Water USP

  • Package Labeling:

    Bottle5

  • INGREDIENTS AND APPEARANCE
    COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 75 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-034-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/202001/31/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/16/202001/31/2026
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)
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