Label: STRATON- alcohol aerosol

  • 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 28, 2022

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  • ACTIVE INGREDIENTS

    ACTIVE INGREDIENTS

    ETHYL ALCOHOL

    CATIONIC SURFACTANT

  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS

    WATER, ANTIOXIDANT, FRAGRANCE, AND PROPELLANT: N-BUTANE, PROPANE

  • INDICATIONS AND USAGE

    HANDS; SHAKE WELL BEFORE USING.

    HOLD CAN VERTICALLY 6 - 8 INCHES FROM THE PALM OF YOUR HANDS AND SPRAY ENOUGH ON THE PALM.

    RUB THE PALM OF YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

  • DOSAGE AND ADMINISTRATION

    SPRAY ENOUGH PRODUCT ON THE PALM TO RUB YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

  • WARNINGS AND PRECAUTIONS

    DO NOT APPLY NEAR FACE OR EYES

    DO NOT ALLOW CHILDREN TO HANDLE THE PRODUCT

    DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

    DO NOT BURN OR PUNCTURE THE CONTAINER,

    DO NOT USE NEAR THE EYES AND FLAME.

    DO NOT EXPOSE TO HEAT, NOR INCINERATE IT.

    DO NOT STORE IN TEMPERATURES ABOVE 124° F.

  • WARNINGS

    FLAMMABLE PRODUCT

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

    ANTIMICROBIAL

  • DO NOT USE

    DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

  • ASK A DOCTOR SECTION

    EYE CONTACT

    INGESTION

    INHALATION

    IN ANY CASE GET MEDICAL ATTENTION AND SHOW THIS LABEL

  • PACKAGE LABEL

    STRATON DISINFECTANT SPRAY 420 mL

  • INGREDIENTS AND APPEARANCE
    STRATON 
    alcohol aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80105-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.4643 mL  in 1 mL
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X) (N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) - UNII:85440928RV) N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)0.0006 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R) 0.2857 mL  in 1 mL
    SODIUM NITRATE N-15 (UNII: 0GNX7H7XF7) 0.0019 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.1513 mL  in 1 mL
    PROPANE (UNII: T75W9911L6) 0.0952 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80105-1000-2420 mL in 1 CAN; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - Aerosoles Francomexicanos, S.A. de C.V. (951582146)
    Registrant - Aerosoles Francomexicanos, S.A. de C.V. (951582146)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aerosoles Francomexicanos, S.A. de C.V.951582146manufacture(80105-1000)
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