Label: PPE GO KIT- ethyl alcohol kit

  • 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 8, 2020

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  • Color Element Hand Sanitizer with Moisturizers and Vitamin E

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 75% v/v

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and water are not available.
  • Warnings

    For external use only.
    Flammable. Keep away from fire and flame
    When using this product do not use in or near the 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 appears on the skin.

    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.
    • Children under 6 years of age should be supervised by adult when applying this product.
    • Do not use on children less than 2 months of age or on open skin wounds.
  • Other information

    • Store between 15-30°C (59-86°F)
    • May discolor some fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol.

  • Color Element Antiseptic Hand wipes saturated with 75% Ethyl Alcohol

    Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Do not use • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop

    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    wet hands thoroughly with wipe and allow to dry without wiping

  • Inactive ingredients

    Purified water

  • Questions or Comments?

    212-551-2657

  • SPL UNCLASSIFIED SECTION

    PPE GO KIT™

    Go Live Your Life

    2 protective face masks 3-ply pleated (non-medical)

    4 hand sanitizer packets 75% alcohol + moisturizers

    2 antibacterial wipes 75% alcohol

    3-Ply Disposable Protective Face mask (Non-Medical)

    • Inner Layer: Non-woven fabric
    • Middle Layer: Non-woven Meltflown filter
    • Outer Layer: Non-woven fabric

    How to wear:

    1) Lay the mask flat

    2) Pull the mask with both hands toward the face

    3) Hold the mask with one hand and pull the ear loops each ear

    4) Pull upper and bottom edge of the mask to cover the area from below your eyes to under chin, push the nosepiece inward with your fingers to conform to the shape of your nose

    Specifications: 17.5 cm x 9.5 cm
    Standard: T/CTCA 7-2019
    Store in a cool and dry place

    Caution:

    1) This product is a single-use protective mask to filter out pollen, bacteria and to block contaminants from oral and nasal exhalation. It is not suitable for infants and children.

    2) The mask is for single use only and can be worn 4-6 hours

    3) In case of discomfort or adverse reactions, discontinue use.

    4) Please store masks in a clean, cool and dry place after opening and use as soon as possible.

    hand sanitizer packets 75% alcohol + moisturizers

    Hand Sanitizer

    • 75% Alcohol + Moisturizers
    • Kills 99.9% of harmful germs
    • Smooth Gel Product
    • 2 ml (.07 fl oz)
    • Registered FDA Brand

    How to use:

    1) Tear off top to dispense.
    2) Rub hands vigorously until dry.

    antibacterial wipes 75% alcohol

    Antibacterial Wipes

    • Antibacterial single use wipe
    • Kills 99.9% of harmful germs
    • For hand washing to reduce bacteria.

    How to use:

    1) Tear off top of packet.

    2) Wet hand thoroughly with wipe.

    3) Use until dry to touch.

    Global Genesis Partners LLC

    75 Executive Drive, Suite 106

    Aurora, IL 60504

    866-466-5487

    www.getgocare.com

    Made in China

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    PPE GO KIT 
    ethyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79110-151
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79110-151-3030 in 1 KIT08/10/2020
    1NDC:79110-151-421 in 1 PACKAGE; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BAG 8 mL
    Part 22 PATCH 8.26 mL
    Part 1 of 2
    COLOR ELEMENT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E 
    alcohol gel
    Product Information
    Item Code (Source)NDC:74934-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    INULIN (UNII: JOS53KRJ01)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2020
    Part 2 of 2
    COLOR ELEMENT ANTISEPTIC HAND WIPES SATURATED WITH 75 ETHYL ALCOHOL 
    alcohol cloth
    Product Information
    Item Code (Source)NDC:74934-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 BOX
    14.13 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/10/2020
    Labeler - Global Genesis Partners Llc (131394303)