Label: CLEANSIFIED- 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 July 7, 2020

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

    Consumer 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

    on 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

    Water, Acrylates Copolymer, Fragrance, Aminomethyl Propanol

  • Package Label - Principal Display Panel

    75673-180-01

    75673-180-02

    75673-180-08

    75673-180-16

    75673-180-32

  • INGREDIENTS AND APPEARANCE
    CLEANSIFIED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75637-180
    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
    WATER (UNII: 059QF0KO0R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4.5 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75637-180-013786 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:75637-180-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    3NDC:75637-180-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    4NDC:75637-180-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    5NDC:75637-180-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - Cleansified (117476725)
    Registrant - Cleansified (117476725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cleansified117476725manufacture(75637-180)
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