Label: COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 70 SOLUTION- alcohol liquid

  • NDC Code(s): 74934-019-01
  • 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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  • 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:

    Label

  • INGREDIENTS AND APPEARANCE
    COLOR ELEMENT ALCOHOL ANTISEPTIC HAND SANITIZER 70 SOLUTION 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-019-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/202001/31/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/11/202001/31/2026
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(74934-019)
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