Label: EWLEKA DISINFECTION GEL- 95%ethanol gel

  • 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 July 2, 2020

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  • Alcohol

    Alcohol80% v/v Purpose: Antiseptic

  • Dosage

    Dosage:

    Take 3ml of this product and apply it to your hands.

    for medical surgery hand disinfection：take 5ml- 10ml of this product

    Administration: topical

  • Warnrings

    1.This product is for external use, strictly forbidden to be taken orally.Please keep it out of reach of children.

    2.This product contains alcohol, do not contact open flames.

    3. This product contains alcohol, it should not be used if you are allergic to alhol.

    4.This product is not suitable for disinfecting the surface of fat-soluble objects.

  • Inactive ingredient

    water

    glycerine

  • Usage

    Take 3ml of this product and apply it to your hands, rub your hands for one minute until it is dry.

    Medical Surgery hand disinfection: Wash your hands, lower 1/3of upperarm as specified, than take5ml-10ml of this product and evenly apply it to yourhands , rub your hands for 3 minutes until it is dry, put onsterile gloves at last.

  • Keep out of reach of children

    This product is for external use ,strictly forbidden to be taken orally.

  • Purpose

    It is used for hand disinfection.

  • Active ingredient

    Active ingredient: ethanol

  • The labeling of Disinfection Gel

    500ml label500ml NDC ：79239-001

  • INGREDIENTS AND APPEARANCE
    EWLEKA DISINFECTION GEL 
    95%ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79239-001
    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
    GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79239-001-02500 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 - Keqin Cosmetics（shanghai）Co.,Ltd (554537587)
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