Label: ANTIBACTERIAL HAND SANITIZER- 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 April 15, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use in the eyes. In case of contact, rinse eyes with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep Out of reach of children. If swallowed get medical help or contact poison control center right away.

  • Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • Supervise children in the use of this product.
  • Other Information

    • store at 20-25° C (68 to 77°F)
    • may discolor certain fabrics
  • Inactive Ingredients

    Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60, Almond Glycerides, Aloe Barbadensis Leaf Juice, Triisopropanolamine, Fragrance

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Suavecito, Inc.
    Santa Ana, Calif. 92703

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    SUAVECITO®

    ANTIBACTERIAL
    HAND SANITIZER

    KILLS 99.99% OF ALL GERMS.
    WITH ALOE VERA & VITAMIN E.

    8 fl oz (237 mL)

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74866-714
    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
    Propylene Glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    triisopropanolamine (UNII: W9EN9DLM98)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74866-714-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/15/2020
    Labeler - Suavecito,Inc. (078681797)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc.078831987MANUFACTURE(74866-714) , PACK(74866-714)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suavecito078681797LABEL(74866-714) , PACK(74866-714)
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