Label: CLEANSLATE- 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 January 12, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 75% Purpose: Antiseptic

    Purpose

    Antiseptic

  • Use

    To help reduce bacteria on hands when water & soap are not available

  • Warnings

    For external use only

    Flammable. Keep away from heat or flame

    Do not use

    Do not use

    • On children less than 2 years old
    • On open skin wounds

    When using this product

    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

    Stop use and ask a doctor if skin irritation occurs.

    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

    • Apply onto hands thoroughly, rub together until dry
    • Supervise children under 6 years old
  • Other information

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

    Water, Aminomethyl Propanol, Carbomer, Glycerin, Propylene Glycol, Aloe Barbadensis Extract, Tocopheryl Acetate, Fragrance

  • Package Label - Principal Display Panel

    30 mL NDC: 75601-1271-1 Front & back labels30 mL NDC: 75601-1271-2 Outer box

  • INGREDIENTS AND APPEARANCE
    CLEANSLATE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75601-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75601-1004-21 in 1 BOX10/14/2020
    1NDC:75601-1004-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/14/2020
    Labeler - Punch Studio, LLC (843912440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pretty Tourism Manufacture Co., Ltd.553193489manufacture(75601-1004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Punch Studio, LLC843912440relabel(75601-1004)
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