Label: ALCO-CLOTH- alcohol cloth

  • 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 January 14, 2021

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For use to decrease bacteria on the skin. 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

    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

    Water, hydrogen peroxide.

  • PRINCIPAL DISPLAY PANEL

    90 CT 74146-240-9990 CT 74146-240-99

  • PRINCIPAL DISPLAY PANEL

    225 CT 74146-240-88225 CT 74146-240-88

  • PRINCIPAL DISPLAY PANEL

    90 CT 74146-240-90

  • PRINCIPAL DISPLAY PANEL

    225 CT 74146-240-95225 CT 74146-240-95

  • INGREDIENTS AND APPEARANCE
    ALCO-CLOTH 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-240-996 in 1 BOX12/01/2020
    1NDC:74146-240-90647.3 mL in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:74146-240-884 in 1 BOX12/01/2020
    2NDC:74146-240-95810.1 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - GM Industrial, Inc. (025827197)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Industrial, Inc.025827197manufacture(74146-240) , pack(74146-240) , label(74146-240) , repack(74146-240) , relabel(74146-240)
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