Label: TOK AND CARE SANITIZER- hypochlorous acid liquid

  • 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 June 15, 2021

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

  • Active Ingredient

    Hypochlorous Acid ------ 0.0.007%

  • Purpose

    Antimicrobial

  • Directions:

    Use when soap and water not available to supplement regular hand washing.

    Press the front fingerprint shape to wash hands, skin.

    Or rub hands with a tissue

    Rub suspected tool, furniture, and space.

  • Inactive Ingredient(s)

    Water

  • Intended Use

    For Personal sanitizing to decrease virus and baceteria on skin

  • Warnings:

    For external use only

  • Purpose:

    For personal sanitizing to decrease virus and bacteria on skin

  • 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.

  • 0.27 fl oz (8 mL) PDP

    0.27 fl oz (8mL) NDC 75644-004-01

    TOK AND CARE (8ml)

  • 0.27fl oz (8ml ea) X 10 Pouches PDP

    TOK AND CARE 8 ML 10 POUCHES0.27 fl oz (8ml) X 10 Pouches NDC 75644-004-02

  • 1.69 fl oz (50ml) PDP

    1.69 fl oz (50ml) PDP 75644-004-03 TOK AND CARE 50ml

  • 3.38 Fl oz (100ml) PDP

    3.38 Fl oz (100ml) PDP, NDC: 75644-004-04

    TOK AND CARE 100ml

  • INGREDIENTS AND APPEARANCE
    TOK AND CARE SANITIZER 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75644-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.007 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75644-004-0350 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/18/2021
    2NDC:75644-004-04100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/18/2021
    3NDC:75644-004-0210 in 1 BOX06/18/2021
    3NDC:75644-004-018 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:75644-004-018 mL in 1 POUCH; Type 0: Not a Combination Product06/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2021
    Labeler - KEWS CORPORATION (688640317)
    Registrant - KEWS CORPORATION (688640317)
    Establishment
    NameAddressID/FEIBusiness Operations
    KEWS CORPORATION688640317pack(75644-004) , manufacture(75644-004) , label(75644-004)