Label: IVRESSE SANITIZER DISINFECTANT- alcohol spray

  • NDC Code(s): 78740-004-04
  • Packager: Ivresse Internacional, S.A. de C.V.
  • 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 September 13, 2023

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 94% v/v

    Purpose

    Antiseptic

  • Use

    • Helps reduce bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product:

    • Do not use in the eyes. Rinse with water to remove.
    • Do not puncture or incinerate. Contents under pressure.

    Stop use and ask a doctor 

    If irritation or redness develop and last more than 72 hours.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Spray onto hands at maximun distance of 6 inches.
    • Wet hands thoroughly with product and rub hands together until dry.
    • Do not spray onto face. 
    • Avoid breathing mist and use in well ventilated area.
  • Other Information

    • Do not store above 120 °F
    • May stain some fabrics.
    • Not for use on hard surface. Harmful to wood finishes and plastics.
  • Inactive Ingredients

    Surfactants, Citrus scent, Propellant gas.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    IVRESSE SANITIZER DISINFECTANT 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78740-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.94 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BERACTANT (UNII: S866O45PIG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78740-004-04400 mL in 1 CANISTER; Type 0: Not a Combination Product08/11/202004/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/11/202004/01/2025
    Labeler - Ivresse Internacional, S.A. de C.V. (814233193)
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