Label: LIQUID HAND SOUP ECOSOL- 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 August 18, 2020

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

  • Active Ingredient(s)

    Benzalkonium chloride 0.13%. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    water, potassium cocoate, cocamidopropyl betaine, coco glucoside, sodium benzoate, hydroxyethyl cellulose, lime essential oil.

  • Package Label - Principal Display Panel

    1000 mL NDC: 77993-004-01 PDP 1000 ml

    5000 mL NDC: 77993-004-02 PDP 5000 ml

    20000 mL NDC: 77993-004-03 PDP 20000 ml

    200000 mL NDC: 77993-004-04 PDP 200000 ml

  • INGREDIENTS AND APPEARANCE
    LIQUID HAND SOUP ECOSOL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77993-004
    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
    CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH) 0.07 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 82.9 mL  in 100 mL
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) 0.5 mL  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 5 mL  in 100 mL
    COCO GLUCOSIDE (UNII: ICS790225B) 5 mL  in 100 mL
    POTASSIUM COCOATE (UNII: F8U72V8ZXP) 5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77993-004-011000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    2NDC:77993-004-025000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    3NDC:77993-004-0320000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:77993-004-04200000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Ecosolutions, S. de R.L. de C.V. (814399275)
    Registrant - Ecosolutions, S. de R.L. de C.V. (814399275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecosolutions, S. de R.L. de C.V.814399275manufacture(77993-004) , pack(77993-004) , label(77993-004)