HAND SANITIZER GEL [TROPICAL ENTERPRISES INTERNATIONAL, INC.]

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HAND SANITIZER GEL [TROPICAL ENTERPRISES INTERNATIONAL, INC.]
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NDC 58418-116-00, 58418-116-01, 58418-116-02, 58418-116-04, 58418-116-05, 58418-116-08, 58418-116-10, 58418-116-12, 58418-116-16, 58418-116-28, 58418-116-64
Set ID 6e013ae7-955c-9d9c-e053-2991aa0a2767
Category HUMAN OTC DRUG LABEL
Packager Tropical Enterprises International, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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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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