Label: 4 HOUR POWER HAND SANITIZER- benzalkonium chloride liquid

  • 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 6, 2021

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  • Drug Facts

  • Active ingredient[s]

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use[s]

    Hand sanitizer to help reduce bacteria on the skin that could cause disease.

  • Warnings

    FOR EXTERNAL USE ONLY. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.
    Stop use and ask a doctor if irritation or redness develops, or if 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

    Place enough product on your palm to thoroughly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

  • Other information

    Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Keep out of extreme temperatures.

  • Inactive ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Lauramine Oxide, Dimethyltetradecylamine Oxide, DMDM Hydantoin (preservative), Fragrance*
    *may contain this ingredient

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    ALCOHOL FREE

    FRESH ALOE SCENT

    NON-FLAMMABLE

    DYE FREE

    NON-IRRITATING

    MOISTURIZING FORMULA

    NO STING

    Long Lasting, Kills 99.9% of Germs for Up to 4 Hours

    Outlasts Alcohol-Based Sanitizers by Persisting on Skin

    Alcohol Free Formula Won't Dry Hands, Sting, or Cause Cracking

    Leaves Skin Feeling Nourished and Moisturized

    Paraben-Free, Sulfate-Free, Phthalate-Free

    Foaming Formula

  • Packaging

    IMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    4 HOUR POWER HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77042-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77042-440-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    2NDC:77042-440-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    3NDC:77042-440-013785 mL in 1 JUG; Type 0: Not a Combination Product04/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2021
    Labeler - Guide Energy Solutions LLC (117045830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guide Energy Solutions LLC117045830manufacture(77042-440) , pack(77042-440)
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