Label: SIMPLE HYGIENE ANTIBACTERIAL FOAM HAND- chloroxylenol soap

  • NDC Code(s): 60933-106-01, 60933-106-02, 60933-106-03
  • Packager: Fuller Industries, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.5%

    Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease the bacteria on skin.
    • Recommended for repeated use
  • Warnings

    For external use only

    Do not use 

    in the eyes. In case of contact, flush eyes with water.

    Stop use and ask a doctor if

    • irritatation and redness develop
    • 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

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together to produce a thick lather
    • Rinse and repeat
  • Inactive Ingerdients

    Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, Water

  • Package Labeling:60933-106-01

    Label

  • Package Labeling:60933-106-02

    Label2

  • Package Labeling:60933-106-03

    Label3

  • INGREDIENTS AND APPEARANCE
    SIMPLE HYGIENE ANTIBACTERIAL FOAM HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60933-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60933-106-013790 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2022
    2NDC:60933-106-026 in 1 CASE02/01/2022
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:60933-106-034 in 1 CASE02/01/2022
    33790 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/01/2022
    Labeler - Fuller Industries, LLC (078704329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuller Industries, LLC078704329manufacture(60933-106)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!