Label: CYPRESS BIO-TECH DISINFECTANT HAND WASH- benzalkonium chloride liquid

  • NDC Code(s): 78804-500-00, 78804-500-01, 78804-500-02
  • Packager: Allure Chemicals LP
  • 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 March 11, 2021

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

  • Drug Facts

  • Active Ingredients

    Benzalkonium chloride 0.5%

  • Purpose

    Antibacterial

  • Use[s]

    Hand wash to help reduce bacteria that potentially can cause disease.

  • Warnings

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

    Do not use: on children less than 2 months of age and open skin wounds.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    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 thoroughly with warm water for 30 seconds.

    *Supervise children under 6 years of age when using this product to avoid swallowing.

    *Store between 15-30°C (59-86 °F)

    *Avoid freezing and excessive heat above 40°C (104 °F)

  • Inactive Ingredients:

    Distilled Water, Polyglyceryl-10 Hexaoleate, Na EDTA, Decyl Glucoside, Sodium Cocoamphoacetate, Fragrances, Vitamin E acetate, Phenoxyethanol, Alpha-Cyclodextrin, Aloe Extract, Citric acid

  • SPL UNCLASSIFIED SECTION

    MEDICAL GRADE

    KILLS 99.99% OF VIRUSES & BACTERIA IN 30 SECONDS

    Manufactured for and distributed by

    Cypress Bio-Tech Company Limited

    9820-C Railroad Drive

    El Paso, Texas 79924

    www.cypress-biotech.com

    MADE IN USA

  • Packaging

    IMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    CYPRESS BIO-TECH DISINFECTANT HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78804-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-10 HEXAOLEATE (UNII: 8S25IPV09I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALFADEX (UNII: Z1LH97KTRM)  
    ALOE (UNII: V5VD430YW9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78804-500-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2021
    2NDC:78804-500-002000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2021
    3NDC:78804-500-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/15/2021
    Labeler - Allure Chemicals LP (080442496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Chemicals LP080442496manufacture(78804-500)