Label: FOAMING HAND SANITIZER- indulgence hand sanitizer solution

  • NDC Code(s): 61307-688-10
  • Packager: US Chemical Corporation
  • 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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  • DOSAGE & ADMINISTRATION

    Directions 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, PEG-10 Dimethicone, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria on the skin that could cause diease. Recommended for repeated use.

  • ACTIVE INGREDIENT

    Active Ingredient Ethyl Alcohol 62% v/v

  • 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.

  • PURPOSE

    Purpose Antibacterial Agent

  • WARNINGS

    Warnings For external use only. Flammable. Keep away from fire or flame. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop use and ask a doctor if irritation or rash appears and persists.

  • PRINCIPAL DISPLAY PANEL

    Principal Label

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    indulgence hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-688
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-688-101000 mL in 1 BAG; Type 0: Not a Combination Product07/03/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2012
    Labeler - US Chemical Corporation (031457842)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(61307-688)
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