Label: FRONTLINE HAND SANITIZER - ANTIBACTERIAL- ethyl alcohol 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 August 3, 2020

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  • Drug Facts

  • Active ingredeint[s]

    Ethyl Alcohol 70%v/v

  • Purpose

    Antimicrobial

  • Use[s]:

    To help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings:

    For external use only: on hands. Flammable.

    Keep away from heat or flame. Do not use

    • in children less than 2 months of age
    • on open skin wounds

    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 Irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

  • Directions:

    • Apply to hands thoroughly with product and rub into skin until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information:

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

    Water, Glycerin, Carbomer, Fragrance, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    % 70 Alcohol

    Kills 99.9% of bacteria WITHOUT WATER

    Fast Drying

    Non Sticky

    MADE IN TURKEY

    Distributed by: Sinerji Trade Ltd.

    +90 212 850 8888

    www.sinerji.com.tr

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    FRONTLINE HAND SANITIZER - ANTIBACTERIAL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79853-100
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79853-100-033 mL in 1 POUCH; Type 0: Not a Combination Product08/02/2020
    2NDC:79853-100-055 mL in 1 POUCH; Type 0: Not a Combination Product08/02/2020
    3NDC:79853-100-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    4NDC:79853-100-7070 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    5NDC:79853-100-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    6NDC:79853-100-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    7NDC:79853-100-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    8NDC:79853-100-55500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    9NDC:79853-100-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    10NDC:79853-100-515000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/02/2020
    Labeler - DINAMO KOZMETIK VE TEKSTIL DIS TICARET ANONIM SIRKETI (533088658)
    Establishment
    NameAddressID/FEIBusiness Operations
    DINAMO KOZMETIK VE TEKSTIL DIS TICARET ANONIM SIRKETI533088658manufacture(79853-100)
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