Label: HANDPOWER CLEANER (TM) 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 December 31, 2021

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  • Active Ingredient

    Active Ingredient_____________________________________Purpose

    Benzalkonium Chloride 0.1% ………………………………..……... Antiseptic

  • Purpose

    Active Ingredient_____________________________________Purpose

    Benzalkonium Chloride 0.1% ………………………………..……... Antiseptic

  • Uses.

    Uses: Hand sanitizer to help reduce bacteria and other pathogens that potentially can cause disease. For use when soap and water are not available. Not for use on the face or other sensitive areas.

  • Warnings:

    Warnings: FOR EXTERNAL USE ONLY. DO NOT DRINK. Do not use on food surfaces or pets. Do not combine with other chemicals.

    DO NOT USE on children less than 6 months of age.

  • When using this product

    When using this productkeep out of eyes, ears, mouth, and other body openings. In case of contact with eyes, rinse eyes thoroughly with water, remove contact lenses and continue rinsing eyes.

  • Stop use

    Stop use and ask a doctor if irritation or rash occurs.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

    Poison control hotline: 1 (800) 222-1222

  • Directions:

    Directions:Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 9 years of age when using this product to avoid swallowing.

  • Other information:

    Other information: Store between 10-30C (50-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients:

    Non-Sterile solution

    Inactive ingredients: Glycerin USP, natural fragrance from citrus peels, water

    FDA REGISTERED NDC # 76915-1001-1

  • Part of bottom of rear label

    Proudly made in USA by Handpower Solutions Inc QA inspected and passed by: DG & DA

    www.HandPowerCleaner.com

    (UPC bar code 6 89227 29018 2)

  • Photo of rear of bottle with rear label

    Photo of rear of bottle with rear label

  • Photo of front of product with front label

    Front photo of product and front label

  • INGREDIENTS AND APPEARANCE
    HANDPOWER CLEANER (TM) HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76915-1001
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.0025 mL  in 1 mL
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP) 0.004 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76915-1001-13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/09/2020
    Labeler - handpower solutions inc (130855904)
    Registrant - handpower solutions inc (130855904)
    Establishment
    NameAddressID/FEIBusiness Operations
    handpower solutions inc130855904manufacture(76915-1001)
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