Label: ACTIVE BARRIER ADVANCED HAND SANITIZER- alcohol gel

  • NDC Code(s): 67555-168-01, 67555-168-10
  • Packager: Pronova Corporation
  • 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 June 23, 2020

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

  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use: Hand Sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Warnings: For external use only.

    FLAMMABLE. Keep away from flame or high heat.

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and consult a physician if irritation and redness develop.

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply a dime-sized portion to hands, rub to distribute. Allow to dry.

  • STORAGE AND HANDLING

    Other information: Store below 110°F (43°C)

    May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Methylcellulose, Acrylates/Octalacrylamide Copolymer, Aminomethyl propanol, Water, Isopopanol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol Glycerin, Isopropyl Myristate, Tocopheryl Acetate.

  • QUESTIONS

    Questions: (866) 703-3508

  • SPL UNCLASSIFIED SECTION

    70% ETHYL ALCOHOL

    SPECIFICALLY FORMULATED FOR HEALTH CARE PROFESSIONALS

    MOISTURIZERS & EMOLLIENTS

    ALOE VERA & VITAMIN E

    CHG COMPATIBLE

    KILLS MORE THAN 99.9% OF GERMS

    MADE IN USA

    Manufactured in the USA for:

    Active Barrier LLC. Scituate, MA 02066

    www.activebarrier.net

    Distributed by:

    Pronova Corporation Miami, FL 355155

  • Packaging

    image description

    Actv1g

  • INGREDIENTS AND APPEARANCE
    ACTIVE BARRIER  ADVANCED HAND SANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67555-168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67555-168-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    2NDC:67555-168-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - Pronova Corporation (111421496)