Label: HAND SANITIZER- ddab liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 10, 2021

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  • Active Ingredient(s)

    DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    leuconostoc/radish root ferment, loureirin B, purified water USP

  • Package Label - Principal Display Panel

    300 ml refill60ml label300 ml label60 ml NDC: 80018-101-01

    300 ml NDC: 80018-101-02

    300 ml refill NDC: 80018-101-03

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ddab liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80018-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM BROMIDE (UNII: 72L098XL5Y) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM BROMIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LOUREIRIN B (UNII: P47L69798O)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80018-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:80018-101-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:80018-101-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2020
    Labeler - Bellwishes Corporation (657457541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bellwishes Corporation657457541manufacture(80018-101)
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