Label: HAND SANITIZER- hypochlorous acid gel

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

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Drug Label Information

Updated June 4, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

    Hypochlorous Acid (0.0005% volume/volume (v/v)).

    Triethanolamine (1.2% v/v).

    Edetic Acid (0.05% v/v).

    Carbopol (1.0% v/v).

    Demineralized water.

  • Active Ingredient(s)

    Hypochlorous Acid 0.0005% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Antiseptic hand sanitizer to reduce germs on skin. For use when soap and water are not available.

  • Warnings

    For external use only. Keep out of reach of children.

  • 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, rash or redness 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, rash or redness 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

    Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    Store below 83F (30C)

    Avoid freezing.

  • Inactive ingredients

    demineralized water, triethanolamine, carbomer and stabilizers

  • Package Label - Principal Display Panel

    250 mL NDC: 75432-002-01

    8 oz clorigel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hypochlorous acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75432-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.0005 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 1.2 mL  in 100 mL
    EDETIC ACID (UNII: 9G34HU7RV0) 0.05 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75432-002-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/30/2020
    Labeler - Medek, LLC (055524072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medek, LLC055524072manufacture(75432-002)
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