Label: HAND SANITIZER GEL- ethyl alcohol gel

  • 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 June 29, 2020

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient(s)

    Ethyl Alcohol 61% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria and viruses on the skin which could cause illness or disease. Recommended for repeated use.

  • Warnings

    Flammable. Keep away from heat or flame.

    For external use only

  • Do not use

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

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

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

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

  • 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 immediately.

  • Directions

    • Apply enitre package contents onto hands and rub until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110 o F (43 o C)
    • May discolor certain fabrics or surfaces
    • www.ViRlogix.com
  • Inactive ingredients

    Purified Water, Glycerol, Carbomer 940, Hydrogen Peroxide, Trolamine, Eucalyptus Oil

  • Package Label - Principal Display Panel

    NDC: 77183-8067-2

    24 POUCHES in 1 BOX > .0025L in 1 POUCH

    60 mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77183-8067(NDC:73809-8067)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL61 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77183-8067-10.0025 L in 1 BOX; Type 0: Not a Combination Product06/03/202006/03/2020
    2NDC:77183-8067-224 in 1 BOX06/10/2020
    20.0025 L in 1 POUCH; Type 0: Not a Combination Product
    3NDC:77183-8067-3500 in 1 BOX06/10/2020
    30.0025 L in 1 POUCH; Type 0: Not a Combination Product
    4NDC:77183-8067-42500 in 1 BOX06/10/2020
    40.0025 L in 1 POUCH; Type 0: Not a Combination Product
    5NDC:77183-8067-51000 in 1 BOX06/10/2020
    50.0025 L in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    Labeler - Tekna Fill, Inc. (081509076)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tekna Fill, Inc.081509076repack(77183-8067)
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