Label: CIRCLE B MANUFACTURING FOAMING ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

  • 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 1, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antimicrobial

  • Uses

    - For hand sanitizing to decrease the bacteria on skin.
    - Recommended for repeated use

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor

    if irritation or redness develops, or if condition persists for more than 72 hours.

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control center right away.

  • DIRECTIONS

    - Pump a small amount of foam into palm of hand
    - Rub thoroughly over all surfaces of both hands
    - Rub hands together to produce a thick lather

  • Inactive ingredients:

    Water, Lauramine Oxide, Undeceth-7, Disodium EDTA, DMDM Hydantoin, Fragrance, Citric Acid, FD&C Red #33, FD&C Blue #1.

  • Package Labeling:3790ml

    Bottle

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    CIRCLE B MANUFACTURING FOAMING ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81458-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    UNDECETH-7 (UNII: R6B5PCO2JN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81458-000-013790 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2020
    2NDC:81458-000-024 in 1 PACKAGE08/19/2020
    23790 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/19/2020
    Labeler - Circle B Manufacturing, Inc. (117798339)
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