Label: CREATIONS GARDEN 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 May 4, 2011

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  • 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, Distearyldimondium Chloride, Cetyl Alcohol, Glycerin, Tocopheryl (Vitamin E) Acetate, Allantoin, Tetrasodium EDTA

  • Questions?

    661-877-4280

  • PRINCIPAL DISPLAY PANEL

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    CG_Peach_Sanitizer_label

  • INGREDIENTS AND APPEARANCE
    CREATIONS GARDEN  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 CHLORIDE0.59 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-006-2459 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2011
    Labeler - Creations Garden Natural Products (961956229)
    Registrant - Creations Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products961956229manufacture
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