Label: EPI-CLENZ PURE INSTANT HAND ANTISEPTIC- ethyl alcohol gel

  • NDC Code(s): 53329-203-04, 53329-203-06
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

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  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • health care personnel hand rub to help reduce bacteria that potentially can cause disease
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    • in the eyes. In case of eye contact, immediately flush with water.

    Stop use and ask a doctor if

    • irritation or redness develop
    • condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands thoroughly with product
    • rub hands together covering all surfaces until hands are dry.
  • Other information

    • Avoid excessive heat. Protect from freezing.
  • Inactive ingredients

    Aloe barbadensis leaf juice, aminomethyl propanol, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, tocopheryl acetate

  • Principal Display Panel

    53329-203-04

  • INGREDIENTS AND APPEARANCE
    EPI-CLENZ PURE INSTANT HAND ANTISEPTIC 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-203-06473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/02/201201/31/2022
    2NDC:53329-203-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/02/2012
    Labeler - Medline Industries, LP (025460908)
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