Label: ACTIVECLEAN- ethanol sda 3c 200 aerosol, spray

  • 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 December 12, 2016

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Shake container. Use enough product to throughly cover hands. Rub hands together briskly until dry. Children under 6 use only with adult supervision.

  • WARNINGS

    For External Use only. Flammable. Keep away from fire or flame.When using the product, do not use it in or near the eyes. In case of contact, rinse eyes throughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. If swallowed get medical help or contact a PoisonControl Center right away.

  • INACTIVE INGREDIENT

    water, isopropyl alcohol (rubbing alcohol), beeswax, apricit seed oil, tocopherol (Vitamin E), essential oils of lemon and peppermint,(epsilon) - polylysine

  • PURPOSE

    Antimicrobial

  • ACTIVE INGREDIENT

    Ethanol 62% v/v

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    • Hand sanitizer to help reduce bacteria on skin that could cause disease
    • Recommended for repeated use
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ACTIVECLEAN 
    ethanol sda 3c 200 aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71012-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mL  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 1 mL  in 1 mL
    APRICOT SEED OIL (UNII: 54JB35T06A) 1 mL  in 1 mL
    LEMON OIL (UNII: I9GRO824LL) 1 mL  in 1 mL
    PEPPERMINT OIL (UNII: AV092KU4JH) 1 mL  in 1 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71012-111-601 in 1 CONTAINER12/01/2016
    13 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2016
    Labeler - CleanSpot, Inc. (078510110)
    Establishment
    NameAddressID/FEIBusiness Operations
    CleanSpot, Inc.078510110manufacture(71012-111)