Label: ECOPURE HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 16, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial

  • Uses

    to help reduce germs and bacteria on the skin

  • Warnings

    For external use only

    • Flammable
    • Keep away from sources of fire or heat
    • Do not ingest

    When using this product

    avoid contact with eyes. If contact with eyes occurs, rinse thoroughly with clean water.

    STOP AND CONSULT YOUR DOCTOR

    If irritation or redness occurs

    Keep out of Reach of Children.

    In case of accidental ingestion contact the your local or national poison control center immediately 1-800-222-1222

  • Directions

    • Wet hands thoroughly with product and rub together vigorously until dry.
  • Other information

    Store at a temperature below 106° degrees F (41° C)

  • Questions or comments:

    888-735-3621

  • Inactive ingredients:

    D-Water, Aloe Vera (Leaf), Isopropyl Alcohol, Glycerin, Propylene Glycol, hydrogen Peroxide, Carbomer, Triethanolamine, Fragrance, FD&C Blue #1 and Yellow #5

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ECOPURE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79241-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79241-000-00429 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Adrian Rivera Maynez Enterprises Inc (013690640)
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