Label: BIOWASH HAND ANTISEPTIC- hi iq water spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 20, 2021

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

  • Active Ingredient

    Hydrogen Cation .77%

  • Purpose

    Antiseptic

  • Uses

    For spraying on hands or hard surfaces in order to help prevent the spreading of bacteria & harmful germs.

  • Warnings

    For external use only. Do not use if you are allergic to any ingredients. Stop use if rash develops and ask a doctor right away.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children

  • Directions

    Spray solution on hard surfaces or hands. Allow hands to dry. For maximum efficacy on surfaces, we recommend drying with a BioFoam™ Mitt, a BioFoam™ Sponge, or a BioFoam™ Wipe.

  • Other Safety Information

    Store under 110º F (43º C)

  • Inactive Ingredients

    Water, Urea

  • BIOWASH HAND ANTISEPTIC

    39 BIOWASH 1.7 oz HAND ANTISEPTIC.jpg

  • INGREDIENTS AND APPEARANCE
    BIOWASH HAND ANTISEPTIC 
    hi iq water spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76701-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN CATION (UNII: 5046UKT60S) (HYDROGEN CATION - UNII:5046UKT60S) HYDROGEN CATION10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 940 mg  in 1 mL
    UREA (UNII: 8W8T17847W) 50 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76701-315-0250.275 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2021
    2NDC:76701-315-08237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2021
    3NDC:76701-315-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/11/2021
    Labeler - Hand Sanitizer LLC (117473019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hand Sanitizer LLC117473019manufacture(76701-315) , label(76701-315) , pack(76701-315)