Label: B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL- 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 February 7, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • DRUG FACTS

  • Active ingredient

    Ethyl Alcohol 65% 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 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

    • tear open packet and apply entire amount of gel 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&C Yellow # 10, FD&C Yellow #5, FD&C Blue #1

  • Package Labeling

    Image 200

  • INGREDIENTS AND APPEARANCE
    B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    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:52490-201-10500 in 1 CARTON02/01/2018
    11.2 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2018
    Labeler - Midway Advanced Products, LLC (962765009)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!