Label: EXCEL HAND SANITIZER- alcohol soap

  • NDC Code(s): 53125-800-57, 53125-800-88
  • Packager: Superior 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 20, 2020

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  • Active Ingredient

    Active Ingredient

    Ethyl Alcohol 70%

  • Uses

    Uses

    • Use hand sanitizer to reduce microorganisms on the skin.
    • Use this product when soap and water are not available.

  • Warnings

    Warnings

    • For external use only. Do not ingest.
    • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
    • Avoid contact with eyes. In case of eye contact, flush with large quantities of water, seek medical attention if irritation persists.
    • If skin irritation develops, discontinue use. If irritation persists for more than 72 hours, seek medical attention.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Directions

    Read the entire label before using this product.

    Place enough product on your palm to thoroughly cover your hands.

    Rub hands together briskly until dry.

  • Inactive Ingredients

    Inactive Ingredients
    Water, PEG-10 Dimethicone, Propylene Glycol, Fluorinated Alcohol, Fluorinated Polymer, Aloe Barbadensis
    Leaf Juice, Fragrance, Acid Green 25.

  • Purpose

    Purpose

    Antiseptic

  • North Woods DermaFoam Excel Hand Sanitizer

    KEEP OUT OF REACH OF CHILDREN

  • North Woods DermaFoam Excel Hand Sanitizer

    Superior Excel

  • INGREDIENTS AND APPEARANCE
    EXCEL HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53125-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    2-SEC-BUTYL CYCLOHEXANONE (UNII: 5WA6R1KL5J)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOPROPYLPHENYLBUTANAL (UNII: Z92022479Y)  
    HEXYL ACETATE (UNII: 7U7KU3MWT0)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    TETRAHYDROLINALYL ACETATE (UNII: 2NDV3959AX)  
    EBANOL (UNII: 28N247O58B)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53125-800-57550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    2NDC:53125-800-88500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - Superior Chemical Corporation (023335086)
    Registrant - Betco Corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(53125-800) , label(53125-800)
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