Label: CLEANINFUL INSTANT HAND SANITIZER- alcohol liquid

  • NDC Code(s): 79126-002-01, 79126-002-02, 79126-002-03, 79126-002-04, view more
    79126-002-05, 79126-002-06
  • Packager: SBC International Group Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial

  • Uses:

    • Decreases bacteria on the skin.
  • WARNINGS

    For external use only.

    Flammable. Keep away from heat or flame. 

    When using this product,

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if

    redness or irritation develops & persists for more than 72 hours.

    Keep out of the 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.
    • Children under 6 years of age, use only under adult supervision.
  • Other Information:

    • Do not store above 1050F (430C). 
    • May discolor some fabrics and surfaces.
  • Inactive ingredients:

    WATER, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, PHENOXYETHANOL, TRIETHANOLAMINE, FRAGRANCE, VITAMIN E

  • Package Labeling:59ml

    Bottle2

  • Package Labeling:118ml

    Bottle3

  • Package Labeling:236ml

    Bottle4

  • Package Labeling:473ml

    Bottle5

  • Package Labeling:3.785L

    Bottle6

  • Package Labeling: 947mL

    947

  • INGREDIENTS AND APPEARANCE
    CLEANINFUL INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79126-002
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79126-002-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/202002/01/2023
    2NDC:79126-002-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/202002/01/2023
    3NDC:79126-002-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/202002/01/2023
    4NDC:79126-002-04473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/202002/01/2023
    5NDC:79126-002-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/202002/01/2023
    6NDC:79126-002-06947 mL in 1 BOTTLE; Type 0: Not a Combination Product11/25/202002/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/08/202002/01/2023
    Labeler - SBC International Group Inc. (117520462)
    Establishment
    NameAddressID/FEIBusiness Operations
    SBC International Group Inc.117520462manufacture(79126-002)
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