Label: HAND SANITIZER gel

  • NDC Code(s): 83254-005-01, 83254-005-02, 83254-005-05, 83254-005-06, view more
    83254-005-10, 83254-005-12, 83254-005-20, 83254-005-25, 83254-005-36, 83254-005-37, 83254-005-50, 83254-005-55
  • Packager: 1201258 Ontario Inc.
  • 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 July 14, 2023

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  • SPL UNCLASSIFIED SECTION

    1. Alcohol (ethanol)- USP (66.5%, volume/volume (v/v))
    2. Sterile distilled water or boiled cold water.

  • Active Ingredient(s)

    Alcohol 66.5% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of 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 occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    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.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Isopropyl alcohol 3.5%v/v, Carbomer 941, Glyceryl acrylated/acrylic acid copolymer, Lime Oil, PEG-40 Hydrogenated Castor Oil, Aloe Vera Juice, Triethanolamine, Purified Water

  • Package Label - Principal Display Panel

    For all package size

    Example of Plastic Bottle

    20ML NDC: 80129-005-01

    50ML NDC: 80129-005-02

    60ML NDC: 80129-005-03

    100ML NDC: 80129-005-04

    250ML NDC: 80129-005-05

    500ML NDC: 80129-005-06

    1000ML NDC: 80129-005-07

    2000ML NDC: 80129-005-08

    3785ML NDC: 80129-005-09

    5000ML NDC: 80129-005-10

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.3 g  in 100 mL
    LIME OIL (UNII: UZH29XGA8G) 0.3 g  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 g  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 3.5 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.75 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.55 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 100 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83254-005-0220 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    2NDC:83254-005-0550 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    3NDC:83254-005-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    4NDC:83254-005-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    5NDC:83254-005-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    6NDC:83254-005-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    7NDC:83254-005-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    8NDC:83254-005-202000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    9NDC:83254-005-373785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    10NDC:83254-005-555000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    11NDC:83254-005-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    12NDC:83254-005-36360 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2020
    Labeler - 1201258 Ontario Inc. (256906595)
    Registrant - 1201258 Ontario Inc. (256906595)
    Establishment
    NameAddressID/FEIBusiness Operations
    1201258 Ontario Inc.256906595manufacture(83254-005) , pack(83254-005) , label(83254-005)
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