B4 (ETHYL ALCOHOL) GEL [MIDWAY ADVANCED PRODUCTS, LLC]

B4 (ETHYL ALCOHOL) GEL [MIDWAY ADVANCED PRODUCTS, LLC]
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NDC 52490-100-11
Set ID eb12fe9c-4050-4432-91a4-48792f29fa48
Category HUMAN OTC DRUG LABEL
Packager Midway Advanced Products, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Ethyl Alcohol 62% w/w

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  • Purpose

    Antimicrobial

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  • Uses

    • To sanitize hands without water.
    • Kills 99% of most common bacteria.
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  • Warnings

    FLAMMABLE

    For external use only.

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  • When using this product

    • keep away from fire or flame.
    • do not use in the eyes.
    • discontinue use if irritation or redness develop.
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • apply gel liberally to unsoiled hands.
    • rub in thoroughly until hands are dry.
    • do not wipe or use water rinse.

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  • Other information

    • Store at room temperature.
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  • Inactive ingredients

    Water, Aloe Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D and C Yellow #10, FD and C Yellow #5, FD and C Blue #1

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  • Distributed by

    Midway Advanced Products, LLC
    1-713-629-5200
    800 Town and Country Blvd,  Suite 200, Houston, TX 77024

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  • Principal Display Panel

    B4

    HAND SANITIZER
    ENRICHED WITH ALOE
    KILLS GERMS | ANTIBACTERIAL
    Over 50% of after tax profits from B4
    support Green and charitable causes.
    B4products.com

    Net 18.0 Fl Oz (532 ml)

    Bottle Label

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  • INGREDIENTS AND APPEARANCE
    B4   HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52490-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 42 mg  in 25 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Diisopropylamine (UNII: BR9JLI40NO)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52490-100-11 532 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/15/2010
    Labeler - Midway Advanced Products, LLC (962765009)
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