Label: HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     58418-116-00, 58418-116-01, 58418-116-02, 58418-116-04, view more
    58418-116-05, 58418-116-08, 58418-116-09, 58418-116-10, 58418-116-12, 58418-116-15, 58418-116-16, 58418-116-18, 58418-116-25, 58418-116-28, 58418-116-32, 58418-116-55, 58418-116-64, 58418-116-70, 58418-116-99
  • Packager: Tropical Enterprises International, 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 February 3, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • DOSAGE AND ADMINISTRATION

    Directions: Wet hands thoroughly with product and allow to dry without wiping.

  • INACTIVE INGREDIENT

    InActive Ingredients: Water, Carbomer, Triethanolamine

  • INDICATIONS AND USAGE

    Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek prompt medical attention.

  • OTC PURPOSE

    Purpose... Antiseptic

  • WARNING

    WARNINGS: For external use only

    When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.

    Stop use and ask a doctor if irritation or redness develops and persists. If swallowed, seek prompt medical attention.

  • OTHER SAFETY INFORMATION

    Other information: Non-staining, may discolor certain fabrics.

  • SAFE HANDLING WARNING

    Flammable: Keep away from open flame.

    Avoid freezing and excessive heat above 40C (104F).

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    30ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL20.4 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-116-0010 mL in 1 PACKET; Type 0: Not a Combination Product08/01/2012
    2NDC:58418-116-0515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
    3NDC:58418-116-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
    4NDC:58418-116-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
    5NDC:58418-116-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
    6NDC:58418-116-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
    7NDC:58418-116-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    8NDC:58418-116-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    9NDC:58418-116-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    10NDC:58418-116-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    11NDC:58418-116-28840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    12NDC:58418-116-70211200 mL in 1 DRUM; Type 0: Not a Combination Product02/02/2020
    13NDC:58418-116-321228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product02/02/2020
    14NDC:58418-116-1545 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
    15NDC:58418-116-1852 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
    16NDC:58418-116-5530 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/01/2012
    17NDC:58418-116-993840 mL in 1 JUG; Type 0: Not a Combination Product02/02/2020
    18NDC:58418-116-09240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/02/2017
    19NDC:58418-116-25960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2012
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
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