Label: INSTANT HAND SANITIZER CONVENIENCE PACK- 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 November 8, 2018

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

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    For handwashing. Decreases bacteria on skin

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame

    Stop use and ask a doctor

    if rash or irritation develops

    if condition persists for more than 72 hours consult a doctor

    When using this product

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Apply onto hands and rub until dry

    Children under 6 months: Ask a doctor

  • Inactive Ingredients

    Aloe barbadensis Leave Juice, Carbomer, Fragrance, Glycerin, Triethanolamine, Water

  • Product labeling

    label

  • PRINCIPAL DISPLAY PANEL

    label

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER CONVENIENCE PACK 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-600
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-600-061 in 1 KIT01/05/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 BOTTLE 90 mL
    Part 23 BOTTLE 90 mL
    Part 1 of 2
    HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:63940-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-002-0130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2015
    Part 2 of 2
    HAND SANITIZER WITH ALOE 
    alcohol gel
    Product Information
    Item Code (Source)NDC:63940-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-001-0130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2015
    Labeler - Harmon Stores Inc (804085293)