Label: BKLEN HANDS SANITIZER- 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 November 18, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl alcohol 70% 

    Purpose

    Antiseptic

  • Uses:

    To decrease bacteria on the skin that could cause disease. Recommended for repeated use

  • Warnings:

    For external use only: Hands/ Flammable, keep away from fire or flame.

    When using this product:

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water/ Avoid contact with broken skin/ Do not inhale or ingest.

    Stop use and ask a doctor if

    Irritation and redness occurs/ Condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • Other information:

    Do not store above 105° F. May discolor some fabrics. Harmful to wood finishes and plastics

  • Inactive ingredients:

    Water, carbomer, aloe, glycerin, isopropyl myristate, tocopheryl acetate

  • Questions?

    Visit www.bklen.com / contact@bklen.com

  • Package Labeling:59.1ml

    Bottle

  • Package Labeling:236.5ml

    Bottle2

  • Package Labeling:473.1ml

    Bottle3

  • Package Labeling:946.3ml

    Bottle4

  • Package Labeling:3784.6ml

    Bottle5

  • INGREDIENTS AND APPEARANCE
    BKLEN HANDS SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81081-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81081-000-0159.1 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    2NDC:81081-000-02236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    3NDC:81081-000-03473.1 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    4NDC:81081-000-04946.3 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    5NDC:81081-000-053784.6 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/09/2020
    Labeler - Garflo Inc (061488252)
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