Label: LEWCIZER 3- alcohol liquid

  • 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 October 28, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

  • Active Ingredient(s)

    Alcohol 80% 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

    hydrogen peroxide, aloe vera gel, sterile water

  • Package Label - Principal Display Panel

    500 mL NDC: 74829-359-08

    500 mL

    946.35 mL NDC: 74829-359-04

    946.35 mL NDC: 74829-359-04

    3785.41 mL NDC: 74829-359-01

    Gallon

    18927.06 mL NDC: 74829-359-05

    Pail

    208197.65 mL NDC: 74829-359-50

    Drum

    1040988.24 mL NDC: 74829-359-25

    Tote

    3785.41 mL NDC: 74829-359-01IS2

    3785.41 mL NDC: 74829-359-01IS2

  • INGREDIENTS AND APPEARANCE
    LEWCIZER 3 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74829-359
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 4.2 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1.8 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74829-359-04946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    2NDC:74829-359-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    3NDC:74829-359-0518927.06 mL in 1 PAIL; Type 0: Not a Combination Product04/16/2020
    4NDC:74829-359-50208197.65 mL in 1 DRUM; Type 0: Not a Combination Product04/22/2020
    5NDC:74829-359-251040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/22/2020
    6NDC:74829-359-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2020
    Labeler - A.P. Nonweiler Co., Inc. (006069298)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.P. Nonweiler Co., Inc.006069298manufacture(74829-359)
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