Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 67623-002-01, 67623-002-02, 67623-002-03, 67623-002-04, view more
    67623-002-05
  • Packager: Biocosmetica Excel Argentina
  • 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 April 12, 2023

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  • Active Ingredient

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    Decreases bacteria on skin that pontetially can cause disease

    Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame

    When using this product, avoid contact with eyes, ears and mouth. In case of contact with eyes flush thoroughly with water.

  • Do not use

    • In children less than 2 months of age.
    • On open skin wounds.
  • WHEN USING

    When using this product, avoid contact with eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water.

    Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours.

    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 redness or irritation develops & persits for more than 72 hours.

  • 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

    • Wet hands thoroughly with product and allow to dry.
    • Children under 6 years of age, use only under adult supervision.
  • Inactive ingredients

    Water (Aqua), Carbomer, Triethanolamine, Fragrance (Parfum), Phospholipids, Polyquaternium-16, BHT, Panthenol, Niacinamide, Dimethicone, Bisabolol, Phenoxyethanol, Tocopheryl Acetate, CI 16035

    Fromsoybean lecithin. FD&C RED 40.

  • Other Information

    Do not store above 105F (43C).

    May discolor some fabrics and surfaces.

  • PRINCIPAL DISPLAY PANEL

    EXEL

    ALCOHOL EN GEL ANTIMICROBIANO

    con liposomas humectantes y suavizantes

    ALCOOL GEL ANTIMICROBIANO

    com lipossomas de acao humectante e suavizante

    HAND SANITIZER

    with moisturizing and softening liposomes

    BIOCOSMETICA PROFESIONAL

    1.69 fl. Oz/50 ml e

    USA-490-TODOS-0720

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67623-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) (UNII: 1KX12A42IJ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67623-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    2NDC:67623-002-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    3NDC:67623-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    4NDC:67623-002-05475 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    5NDC:67623-002-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - Biocosmetica Excel Argentina (971813332)
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