Label: DG BABY FOAMING 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 April 16, 2019

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  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    to decrease bacteria on the skin

  • Warnings

    For external use only, hands only

  • When using this product

    ■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water ■ avoid contact with broken skin

  • Stop use and ask a doctor if

    ■ irritation or redness develops ■ 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

    ■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision ■ not recommended for infants

  • Inactive ingredients

    cetrimonium chloride, citrus reticulata X C. sinensis peel extract, disodium cocoamphodiacetate, PEG-12 dimethicone, tocopheryl acetate, water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    DG BABY  FOAMING HAND SANITIZER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-989
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-989-80236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2019
    Labeler - Dolgencorp Inc. (068331990)
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