Label: TRUE ESSENTIALS HAND SANITIZER- benzalkonium chloride lotion

  • 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 13, 2011

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

View All Sections
  • Active Ingredient:........................Purpose:

    Benzalkonium Chloride 0.1%........................Antiseptic

  • Use:

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Warnings:

    For external use only--skin.

  • Flammable.

    Keep away from heat and flame.

  • When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
  • Stop use and ask a doctor if

    skin irritation develops.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Wet skin area thoroughly with product
    • Rub hands together until dry
  • Other information

    • Do not store above 105°,
    • May discolor some fabrics,
    • Harmful to wood finishes and plastics.
  • Inactive ingredients

    Water, Pentylene Glycol, Dimethicone, Glyceryl Laurate, Distearyldimonium Chloride, Cetyl Alcohol, Glycerin, Tocopheryl (Vitamin E) Acetate, Allantoin, Tetrasodium EDTA, Blue 1, Yellow 5, Fragrance

  • Questions?

    Call 1-859-422-7048

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text

    Fortune_CumbumberMelon_label



  • INGREDIENTS AND APPEARANCE
    TRUE ESSENTIALS  HAND SANITIZER
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.59 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-006-2359 mL in 1 VIAL, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/13/2011
    Labeler - Fortune Hi-Tech (961956229)
    Registrant - Creations Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products961956229manufacture
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!