Label: KENTEX INSTANT HAND SANITIZER WITH ALOE VERA- alcohol solution

  • 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 2, 2021

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

  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Decrease bacteria on hands

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame

    keep out of eyes. In case of eye contact, immediately flush with water and get medical help

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control immediately

  • Directions

    • Squeeze on hands. Rub hands together until dry
  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Aloe Vera Gel, Propylene Glycol, Vitamin E

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KENTEX INSTANT HAND SANITIZER WITH ALOE VERA 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69556-333
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69556-333-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
    2NDC:69556-333-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
    3NDC:69556-333-321000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
    4NDC:69556-333-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/27/2020
    Labeler - Kentron Healthcare, Inc. (618825723)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU HANHE DAILY CHEMICALS CO., LTD.414409758manufacture(69556-333)