Label: B4- ethyl alcohol gel

  • 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 March 24, 2011

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  • Active ingredient

    Ethyl Alcohol 62% w/w

  • Purpose

    Antimicrobial

  • Uses

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

    FLAMMABLE

    For external use only.

  • When using this product

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

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

  • Directions

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

  • Other information

    • Store at room temperature.
  • 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

  • Distributed by

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

  • 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

  • INGREDIENTS AND APPEARANCE
    B4   HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol42 mg  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52490-100-11532 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2010
    Labeler - Midway Advanced Products, LLC (962765009)
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