Label: CLEACE- ethyl 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 April 7, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help decrease bacteria on the skin, when water, soap & towel are not available.
    • recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes. Do not use in ears & mouth.

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • place enough product into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    • store below 110°F (43°C).
    • may discolor certain fabrics or surfaces.

  • Inactive ingredients

    carbomer, triethanolamine, glycerin, water

  • 1oz CLEACE

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  • 2oz CLEACE

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  • 3.4oz CLEACE

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  • 8oz CLEACE

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  • 10oz CLEACE

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  • 16.9oz CLEACE

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  • 33.8oz CLEACE

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  • 39.9oz CLEACE

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  • 50.7 oz CLEACE

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  • 169.1oz CLEACE

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  • 676.3oz CLEACE

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  • INGREDIENTS AND APPEARANCE
    CLEACE 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74621-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74621-002-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    2NDC:74621-002-0260 mL in 1 PACKAGE; Type 0: Not a Combination Product04/07/2020
    3NDC:74621-002-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    4NDC:74621-002-04237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    5NDC:74621-002-05296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    6NDC:74621-002-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    7NDC:74621-002-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    8NDC:74621-002-081180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    9NDC:74621-002-091500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    10NDC:74621-002-105000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    11NDC:74621-002-1120000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Nanjing Aogrand Int'l Corp (421353092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanjing Aogrand Int'l Corp421353092manufacture(74621-002)