Label: SAN-E-FOAM- otc antimicrobial drug products aerosol, foam

  • 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 January 17, 2020

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  • Active Ingredient:

    Ethyl Alcohol 67%

  • Purpose:

    Antiseptic

  • Uses:

    • For handwashing to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings:

    For external use only.

    Flammable. Keep away from heat or flame.

    Avoid contact with eyes. In case of contact, flush thoroughly with water.

    Stop use and ask a doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion contact a physician or Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product.
    • Briskly rub hands until dry.
    • Supervise children in the use of this product.
  • Other Information

    • Do not store above 105°F. May discolor some fabrics or surfaces.
    • May report serious adverse events to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047
  • INACTIVE INGREDIENT

  • San-E-Foam Package Label Principal Display Panel

    San-E-Foam

  • INGREDIENTS AND APPEARANCE
    SAN-E-FOAM 
    otc antimicrobial drug products aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.67 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-107-1750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/12/2012
    2NDC:61924-107-341000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product10/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/12/2012
    Labeler - Dermarite Industries LLC (883925562)
    Registrant - Dermarite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermarite Industries LLC883925562manufacture(61924-107)
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