Label: DEVONA HAND SANITIZING WIPES- 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 4, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol %70

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product 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 rash appears and lasts.

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

  • Directions

    ■ Wet hands thoroughly with product and allow to dry.
    ■ Children under 6 years of age should be supervised when using the product.

  • Inactive Ingredients

    Purified Water, Glycerin, Triclosan, Essential Oil

  • Other Information

    Store below | 110 ° F (43°C)

  • SPL UNCLASSIFIED SECTION

    + Helps Protect From Viruses and Bacteria

    FDA REGISTERED

    WIPE HANDS

    Turkey Discover the potential

    www.tozmedical.com

    Distributed by Toz Medical LLC Novato, CA
    Made in TURKEY

  • Packaging

    Devona

  • INGREDIENTS AND APPEARANCE
    DEVONA HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78576-415
    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)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78576-415-0150 in 1 BOX06/01/2020
    11 in 1 PACKAGE
    14 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - GULBAHCE KOZM KIMYA TEM URUNLERI KONF AMB SAN VE TIC LTD STI-BURSA NILUFER SUBESI (504451549)
    Establishment
    NameAddressID/FEIBusiness Operations
    GULBAHCE KOZM KIMYA TEM URUNLERI KONF AMB SAN VE TIC LTD STI-BURSA NILUFER SUBESI504451549manufacture(78576-415)
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