Label: FULL CLEAN HAND SANITIZER- alcohol gel

  • 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 March 3, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 65% v/v

    Purpose

    Antiseptic

  • Use

    • Hand sanitizer to help reduce bacteria on the skin that can potentially cause disease.
  • Warnings

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

    Do not inhale or ingest.

    Do not use

    near or in the eyes.

    • In case of contact, flush eyes with water. Avoid contact with broken skin.

    Stop use and ask a doctor if 

    • Irritation or redness develops. 
    • Condition persists for more than 72 hours.

    Keep out of the reach of children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other Information:

    • Store below 110ºf (43ºc). 
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients:

    Water (Aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Hydroxyethyl Cellulose (gelling agent), Triethanolamine (for pH balance).

  • Package Labeling:81167-001-01

    Label

  • Package Labeling:81167-001-02

    Label.2

  • Package Labeling:81167-001-03

    Label3

  • Package Labeling:81167-001-04

    Label.4

  • INGREDIENTS AND APPEARANCE
    FULL CLEAN HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81167-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.65 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81167-001-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2020
    2NDC:81167-001-024000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2020
    3NDC:81167-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2021
    4NDC:81167-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2020
    Labeler - Luxe Tech LLC (117753966)
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