Label: MEDIFRESH ANTISEPTIC HAND AND SKIN DISINFECTANT WET WIPES- ethyl alcohol cloth

  • 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 June 23, 2022

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 80.0 % w / w

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin that could cause disease

  • Warnings

    For external use only.

    Flammable – Keep away from heat or flame

    Do not use
                  • as baby wipe
                  • on open skin wounds
                  • if you are allergic to any of the ingredients

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation, or allergic reaction occurs.

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

  • Directions

    Skin should be rubbed vigorously with the wet wipe. No need to rinse after usage. Allow skin to dry without wiping. For adults and children 2 years and over. Open container plastic cover. Tear off aluminum cover. From center of wipe roll, pull up wipe corner; twist wipe corner from the center plastic cap, thread through the hole. Pull through about one inch. Replace plastic cover. Pull out wipes as needed and snap off at 90º angle. Keep center cap closed to prevent moisture loss. Discard properly after use. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    Store in dry and cool place and away from oxidizers.

    May discolor some fabrics, harmful to wood finishes and plastics.

  • Inactive ingredients

    Aqua, Glycerin, Propylene Glycol, Parfum, Tocopheryl Acetate, Citric Acid, Aloe Barbadensis Extract, Benzalkonium Chloride

  • SPL UNCLASSIFIED SECTION

    Moisturizer

    Aloe Vera

    Vitamin E

    Decrease Bacteria that could cause disease

    Non - Sterile Wet Wipe

    MANUFACTURER
    KARDEŞLER UÇAN YAĞLAR SANAYİ A.Ş.
    İNÖNÜ MAHALLESİ GEBZE
    PLASTİKÇİLER OSB MAHALLESİ
    42.SOKAK NO:1 41400
    GEBZE - KOCAELİ - TÜRKİYE
    T +90 ( 0262 ) 751 29 30 ( Pbx)
    www.kardeslerucanyaglar.com
    info@kardeslerucanyaglar.com

    Made In Turkey

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MEDIFRESH ANTISEPTIC HAND AND SKIN DISINFECTANT WET WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86937-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86937-008-01200 in 1 CANISTER06/22/2022
    11.512 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:86937-008-02200 in 1 BOX06/22/2022
    23.240 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:86937-008-0380 in 1 CANISTER06/22/2022
    31.512 g in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:86937-008-0480 in 1 BOX06/22/2022
    43.240 g in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:86937-008-0560 in 1 BOX06/22/2022
    53.2467 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2022
    Labeler - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)
    Establishment
    NameAddressID/FEIBusiness Operations
    KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI644389322manufacture(86937-008)
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