Label: FRESH N SOFT ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • NDC Code(s): 86937-005-01, 86937-005-02, 86937-005-03
  • Packager: KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI
  • 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 December 23, 2020

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride (0.1%)

  • Purpose

    Antiseptic

  • Use

    Decreases bacteria on the skin that could cause disease

  • Warnings

    For external use only.

    • Do not use as baby wipe.

    • Do not use if you are allergic to any of the ingredients.

    • Do not use on open skin wounds.

    When using this products

    • Do not use in or near the eyes. In case of contact, 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

    • Gently open resealable label, remove and use wipes as required. Keep label closed to prevent moisture loss.

    • No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. • 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.
    • Production date, expiry date and lot number are printed on the pack.

  • Inactive ingredients

    water, phenoxyethanol, propylene glycol, parfum, cocamidopropyl betaine, peg-40 hydrogenated castor oil, benzoic acid, tetrasodium edta, dehydroacetic acid, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    DERMATOLOGICALLY TESTED

    EN 1276

    KARDESLER

    UCAN YAGLAR SANAYI A.S.

    1957

    MANUFACTURER
    KARDESLER UÇAN YAGLAR SANAYI A.S.

    INÖNÜ MAHALLESI GEBZE
    PLASTIKÇILER OSB MAHALLESI
    42.SOKAK NO:1 41400
    GEBZE - KOCAELI - TÜRKIYE
    T +90 ( 0262 ) 751 29 30
    www.kardeslerucanyaglar.com
    info@kardeslerucanyaglar.com

    www.freshnsoft.com

    FreshnSoft

    FreshnSoft

    ISO 22716 Good Manufacturing Practices

    ISO 9001 Quality Management System

    EAC Made in Turkey.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    FRESH N SOFT ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86937-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86937-005-0115 in 1 PACKET12/23/2020
    12.688 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:86937-005-0260 in 1 PACKET12/23/2020
    23.192 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:86937-005-0380 in 1 CANISTER12/23/2020
    32.9792 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 finalpart333A12/23/2020
    Labeler - KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI (644389322)
    Establishment
    NameAddressID/FEIBusiness Operations
    KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI644389322manufacture(86937-005)
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