Label: FOAM 103- antibacterial foaming soap soap

  • 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 January 21, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.15%(w/w)

  • Purpose

    Anitbacterial

  • Use

    Handwash to help decrease bacteria on the skin

  • Warnings

    For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

    Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

  • STOP USE

    Stop use if, in rare instances, redness or irrtiation develops. If condition persists for more than 72 hours, consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • Directions

    To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.

  • Inactive Ingredients

    water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance.

  • Package Label - Principal Display Panel

    3.78 L NDC: 75009-103-01

    3787g label

    18.92 L NDC: 75009-103-02

    18933g label

    208.19 L NDC: 75009-103-03

    208269g label

    1040.98 L NDC: 75009-103-04

    1041556g label

  • INGREDIENTS AND APPEARANCE
    FOAM 103 
    antibacterial foaming soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    HEXYL ACETATE (UNII: 7U7KU3MWT0)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW) 1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75009-103-013787 g in 1 JUG; Type 0: Not a Combination Product05/25/2020
    2NDC:75009-103-0218933 g in 1 PAIL; Type 0: Not a Combination Product05/25/2020
    3NDC:75009-103-03208269 g in 1 DRUM; Type 0: Not a Combination Product05/25/2020
    4NDC:75009-103-041041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - Alpha Aromatics (041723545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alpha Aromatics041723545manufacture(75009-103)
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