Label: KLEENLINE- ethyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 October 6, 2020

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  • Drug Facts

  • Active ingredient 

    Ethyl Alcohol 73%

  • Purpose

    Antimicrobial

  • Uses

    • Hand sanitizing to help reduce bacteria on the skin

    • Recommended for repeated use

  • Directions

    Apply liberally to the hands and gently rub until dry.

  • Other information

    Store above 0°C (32°F)

  • Inactive ingredients

    Purified water, Dimethicone, Isopropyl alcohol

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • QUESTIONS

    Questions? Call 1-800-995-4466

  • SPL UNCLASSIFIED SECTION

    BY WAXIE

    FOAM HAND SANITIZER

    ETHANOL ALCOHOL

    INSTANTLY KILLS 99.99% OF TESTED GERMS

    FRAGRANCE-FREE

    PROUDLY MADE IN USA

    Distributed by:

    WAXIE Sanitary Supply
    San Diego, CA 92123

    *Patented formula effectively eliminates 99.99% of tested germs, bacteria and viruses in as little as 15 seconds; long-term protection for up to 12 hrs.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    KLEENLINE 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78168-628
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78168-628-881000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    2NDC:78168-628-993785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/15/2020
    Labeler - Teh Tung Corporation (023729484)
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