Label: IS CLINICAL HAND SANITIZING 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 December 11, 2021

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

  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    to help reduce bacteria on the skin.

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

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

  • WHEN USING

    When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

    When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

  • DOSAGE & ADMINISTRATION

    Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times daily.

  • STORAGE AND HANDLING

    Do not store above 104F/40C

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Water(Aqua), May contain Isopropyl Alcohol

  • PRINCIPAL DISPLAY PANEL

    69219-107-01 120ml69219-107-02 480ml

  • INGREDIENTS AND APPEARANCE
    IS CLINICAL HAND SANITIZING GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69219-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    ROSEMARY (UNII: IJ67X351P9)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69219-105-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - Science of Skincare (006251958)
    Establishment
    NameAddressID/FEIBusiness Operations
    V Manufacturing & Logistics, Inc.825176857manufacture(69219-105)