Label: BLACK DECKER HAND SANITIZER GEL- ethyl alcohol gel

  • 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 July 29, 2020

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

  • Active ingredient

    Ethyl Alcohol 72%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria on the skin

  • WARNINGS

    For external use only

    Flammable: Keep away from heat and flame

    * Avoid contact with eyes. If contact occurs flush eyes thoroughly with clean and cool water

    * Do not ingest or inhale

    Stop use and ask a doctor

    * If irritation or rash appears and lasts.

    Stop use

    * If irritation or redness develops

    Keep out of reach of children

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

  • Directions

    * Put enough product in you palm to cover hands and rub hands together until dry.

    * Children under 6 years should be supervised when using this product.

  • Inactive ingredients

    Water, Glycerin, Tocopheryl Acetate (Vitamin E), Hydroxypropyl Cellulose, Fragrance

  • Principal Display Panel

    Black+Decker Hand Sanitizer Gel

    Kills up to 99.99% of Germs

    Vitamin E

    Our hand sanitizer with moisturizers and Vitamin E is effective at eliminating 99.99% of common harmful germs.

    *Effective at eliminating up to 99.99% of commmon harmful germs. Claim based on in vitro testing. Data on file.

    Distributed by:

    Dynamic Green Products, Inc.

    11757 Katy Fwy Ste 1300

    Houston, TX 77079

    1-855-BIO-OILS

    www.dgpworks.com

    Black_Decker is a registered trademark of Stanley Black & Decker, Inc.

    XX oz (zzzmL) NDC 74631-006-xx

    BD-128oz

    BD-32oz

  • INGREDIENTS AND APPEARANCE
    BLACK DECKER HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74631-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74631-006-073785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/08/2020
    2NDC:74631-006-06946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Dynamic Green Products, Inc. (110949053)
    Registrant - Dynamic Green Products, Inc. (110949053)
    Establishment
    NameAddressID/FEIBusiness Operations
    Packaging Service Co008435950repack(74631-006) , pack(74631-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vertrauen Chemie Solutions Inc080251121pack(74631-006) , repack(74631-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    BPI Coatings Solutions LLC080477067pack(74631-006) , repack(74631-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRENNTAG MID-SOUTH INC122625064analysis(74631-006) , manufacture(74631-006)