Label: SANTI-GEL INSTANT HAND SANITIZER solution

  • NDC Code(s): 50865-056-03, 50865-056-07, 50865-056-12, 50865-056-19, view more
    50865-056-30, 50865-056-34, 50865-056-35, 50865-056-36, 50865-056-38, 50865-056-43, 50865-056-65, 50865-056-66, 50865-056-67, 50865-056-79, 50865-056-82, 50865-056-86, 50865-056-93
  • Packager: Kutol Products Company, Inc.
  • 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 August 24, 2023

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  • WARNINGS

    Flammable. Keep away from heat or flame.

    For external use only.

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

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% v/v.........Antibacterial Agent

  • 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. 

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Isopropyl Mryistate, Aloe Barbadensis leaf, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl Propanol

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

    Children under 6 years of age should be supervised when using this product.

  • PURPOSE

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

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

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • PRINCIPAL DISPLAY PANEL

    50865-056-65.jpg 50865-056-65.jpg

  • INGREDIENTS AND APPEARANCE
    SANTI-GEL INSTANT HAND SANITIZER 
    santi-gel instant hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-056-121200 mL in 1 BAG; Type 0: Not a Combination Product05/22/201305/10/2017
    2NDC:50865-056-19236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
    3NDC:50865-056-30473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
    4NDC:50865-056-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
    5NDC:50865-056-35118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
    6NDC:50865-056-65800 mL in 1 BAG; Type 0: Not a Combination Product05/22/201305/10/2017
    7NDC:50865-056-791892 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2013
    8NDC:50865-056-82800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/201307/17/2016
    9NDC:50865-056-86800 mL in 1 BAG; Type 0: Not a Combination Product05/22/201307/19/2016
    10NDC:50865-056-931200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/201305/10/2017
    11NDC:50865-056-361000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2013
    12NDC:50865-056-66800 mL in 1 BAG; Type 0: Not a Combination Product05/10/2017
    13NDC:50865-056-03208175 mL in 1 DRUM; Type 0: Not a Combination Product05/15/2015
    14NDC:50865-056-38800 mL in 1 BAG; Type 0: Not a Combination Product05/10/2017
    15NDC:50865-056-43236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    16NDC:50865-056-073875 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    17NDC:50865-056-672000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2013
    Labeler - Kutol Products Company, Inc. (004236139)
    Registrant - Kutol Products Company, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-056)
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