Label: W/CLIP PDQ HAND SANITIZER- ethyl alcohol kit

  • 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 December 3, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62% V/V

  • Purpose

    Antimicrobial

  • Uses

    hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

    When using this product avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

    Stop use and ask a doctor if irritation or redness develops.

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

  • Directions

    • wet hands thoroughly with product and rub into skin until dry. • Children under 6 years of age should be supervised by an adult when using.

  • Inactive ingredients

    aloe barbadensis (aloe vera) leaf juice, carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water (aqua).

  • SPL UNCLASSIFIED SECTION

    INSTANT HAND SANITIZER

    with Vitamin E & Other Moisturizers

    CLASSIC

    ALOE VERA

    LAVENDER

    CITRUS ZEST

    KILLS GERMS WITHOUT WATER

    Made in China

    Distributed by: Universal Distribution Center
    96 Distribution Boulevard
    Edison, NJ 08817

  • Packaging

    HSGel1

    HSGel2

  • INGREDIENTS AND APPEARANCE
    W/CLIP PDQ HAND SANITIZER 
    ethyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-127
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-127-241 in 1 KIT; Type 0: Not a Combination Product11/29/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 BOTTLE 273.5 mL
    Part 25 BOTTLE 273.5 mL
    Part 35 BOTTLE 273.5 mL
    Part 45 BOTTLE 273.5 mL
    Part 1 of 4
    HAND SANITIZER CLASSIC 
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:52000-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-126-2454.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/29/2021
    Part 2 of 4
    HAND SANITIZER ALOE VERA 
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:52000-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-128-2454.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/29/2021
    Part 3 of 4
    HAND SANITIZER LAVENDER 
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:52000-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-129-2454.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/29/2021
    Part 4 of 4
    HAND SANITIZER CITRUS ZEST 
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:52000-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-125-2454.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/29/2021
    Labeler - Universal Distribution Center LLC (019180459)
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