Label: PREVENT FOAM SANITIZER- isopropyl alcohol liquid

  • 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 10, 2020

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

  • Drug Facts

  • Active ingredient

    Isopropyl Alcohol 75% v/v

    Purpose

    Antimicrobial

  • Uses

    • For personal hand hygiene to help prevent the spread of bacteria. For occasional use.
  • Warnings.

    Flammable. Keep away from open flame and sources of heat

    Keep out of reach of children.

    Supervise children when they use this product.

    For external use only. If accidental ingestion occurs, call a Poison Control Center immediately.

    Avoid contact with the eyes. If contact occurs, flush eyes with water. If irritation develops, discontinue use and consult a health care practitioner.

  • Directions

    - Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Inactive Ingredients:

    Water, Cocamidopropyl betaine, Bis-PEG-12 Dimethicone, Glyceryl Caprylate, Dimethyl Lauramide, Glycerin, Aloe Barbadensis Leaf Powder, DL-alpha Tocopheryl Acetate (Vitamin E)

  • For domestic/personal care use.

    Store below 43° C (110° F).

    May discolour certain fabrics.

  • Questions :

    1-844-432-6633 Mon -Fri 8am - 4pm (EST)

    Email: info@eco-med.com

  • Package Labeling:

    Bottle

  • Package Labeling:78835-002-37

    Label6

  • INGREDIENTS AND APPEARANCE
    PREVENT FOAM SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78835-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    N,N-DIMETHYLLAURAMIDE (UNII: 04BJ5OT1PA)  
    BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78835-002-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    2NDC:78835-002-373785 mL in 1 JUG; Type 0: Not a Combination Product08/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/30/2020
    Labeler - Eco-Med Pharmaceuticals, Inc. (249183435)