TAZZA (ETHANOL) CLOTH [TERRABOOST MEDIA LLC]

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TAZZA (ETHANOL) CLOTH [TERRABOOST MEDIA LLC]
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NDC 76370-0004-1, 76370-0004-2, 76370-0004-3, 76370-0004-4
Set ID 391cc18f-ce63-5d88-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Tazza Brands East Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Ethanol 70%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • for hand sanitizing to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    ​ Warnings

    For external use only

    Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • take wipe and rub thoroughly over all surfaces of both hands
    • rub hands together briskly to dry
    • dispose of wipe
  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified Water, Vegetable Glycerin, Lavendula Angustifolia (Lavender) Essential Oil, Organic Aloe Barbadensis Leaf Extract, Organic Matricaria Recutita (Chamomile) Flower Extract

  • SPL UNCLASSIFIED SECTION

    Manufactured for Terraboost Media, LLC

    3109 Grand Avenue #300

    Miami, FL 33133

    A Product of Terraboost®

    877-837-7210 • www.tazzabrands.com

  • Cannister

    TAZZA Ethanol Wipes_112017

    76370-0004 Can CH

  • Pouches

    76370-0004 - CHAlcohol Wipes-Pouch

  • INGREDIENTS AND APPEARANCE
    TAZZA 
    ethanol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76370-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76370-0004-1250 in 1 CANISTER08/02/2016
    11.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:76370-0004-21500 in 1 BAG08/02/2016
    21.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:76370-0004-31200 in 1 BAG08/02/2016
    31.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:76370-0004-4240 in 1 CANISTER08/02/2016
    41.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    5NDC:76370-0004-5160 in 1 POUCH08/02/2016
    51.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    6NDC:76370-0004-680 in 1 POUCH08/02/2016
    61.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    7NDC:76370-0004-720 in 1 POUCH08/02/2016
    71.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    8NDC:76370-0004-850 in 1 POUCH08/02/2016
    81.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    9NDC:76370-0004-9100 in 1 POUCH08/02/2016
    91.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    10NDC:76370-0004-040 in 1 POUCH08/02/2016
    101.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/02/2016
    Labeler - Tazza Brands East Inc. (117842371)
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