Label: GREEN CHECK BRANDS- 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 September 2, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient[s]

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use[s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Questions?

    1-800-372-3777

  • PRINCIPAL DISPLAY PANEL - 355 ML Bottle Label

    GREEN CHECK BRANDS™

    HAND
    SANITIZER

    Alcohol Antiseptic 70%
    Aloe Vera & Vitamin E
    Hand Sanitizer Gel Non-sterile Solution

    Effective in eliminating
    most common germs
    and bacteria

    Formula complies
    with FDA guidelines

    12 FL OZ ( 355 ML)

    PRINCIPAL DISPLAY PANEL - 355 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    GREEN CHECK BRANDS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79756-001
    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
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aloe (UNII: V5VD430YW9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Trolamine (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79756-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    2NDC:79756-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    3NDC:79756-001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    4NDC:79756-001-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    5NDC:79756-001-16473 mL in 1 DRUM; Type 0: Not a Combination Product08/01/2020
    6NDC:79756-001-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    7NDC:79756-001-55208175 mL in 1 DRUM; Type 0: Not a Combination Product08/01/2020
    8NDC:79756-001-271040875 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Green Check Brands, LLC (117465931)