Label: FM-24 FOAMING- chloroxylenol soap

  • NDC Code(s): 43097-876-01, 43097-876-07, 43097-876-10, 43097-876-11, view more
    43097-876-12, 43097-876-13, 43097-876-14, 43097-876-15, 43097-876-27, 43097-876-55
  • Packager: People's Janitorial Supply
  • 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 November 7, 2022

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  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.3%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

    if swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box OTC-Dosage & Administration Section

    • wet hands and forearms
    • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
    • scrub thoroughly for 1 minute and rinse
  • Drug Facts Box OTC-Inactive Ingredient Section

    water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

  • Foamy Mango Antiseptic Hand and Body Wash 6876

    product label

    Foamy Mango Antiseptic Hand and Body Wash 6876

  • INGREDIENTS AND APPEARANCE
    FM-24 FOAMING 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43097-876
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ACID RED 1 (UNII: 3365R6427R)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43097-876-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/10/2020
    2NDC:43097-876-07700 mL in 1 BAG; Type 0: Not a Combination Product11/10/2020
    3NDC:43097-876-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/10/2020
    4NDC:43097-876-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2020
    5NDC:43097-876-121000 mL in 1 BAG; Type 0: Not a Combination Product11/10/2020
    6NDC:43097-876-13800 mL in 1 BAG; Type 0: Not a Combination Product11/10/2020
    7NDC:43097-876-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2020
    8NDC:43097-876-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2020
    9NDC:43097-876-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/10/2020
    10NDC:43097-876-55208200 mL in 1 DRUM; Type 0: Not a Combination Product11/10/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/10/2020
    Labeler - People's Janitorial Supply (057299729)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(43097-876)
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