Label: ANTISEPTIC HAND SANITIZER- alcohol gel

  • NDC Code(s): 65055-600-00, 65055-600-01, 65055-600-02
  • Packager: Laboratorios Jaloma S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 March 27, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 62%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only
    Flammable, keep away from fire or flame.

    Do not use 

    in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop 
    • condition persists for more than 72 hours

    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 without wiping

  • Other information

    • do not store above 110°F (43°C)
    • may discolor certain fabrics, or may harm some wood finishes and plastics
  • Inactive ingredients

    Water, glycerin, fragrance, tocopherol acetate, carbomer and triethanolamine.

  • Questions or comments?

    +1 818 763 8698

  • Package Labeling: (65055-600-00)

    Label2Label

  • Package Labeling: (65055-600-01)

    Label3Label4

  • Package Labeling: (65055-600-02)

    Label5Label6

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-600-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
    2NDC:65055-600-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
    3NDC:65055-600-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/24/2020
    Labeler - Laboratorios Jaloma S.A. de C.V. (811122357)
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