Label: BIOWIPES ALCOHOL 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 November 17, 2020

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  • ACTIVE INGREDIENT

    Alcohol 70% v/w

  • PURPOSE

    Antiseptic, Hand sanitizer wipes

  • INDICATIONS & USAGE

    - For hand sanitizing to decrease bacteria and germs on the skin.

    - Apply topically to the skin to help prevent cross contamination.

    - Dries in seconds

    - Anticeptic wipe to help reduce bacteria and germs potentially can cause disease. For use when soap an water are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame. Not recommended for repeated use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    - Children under 2 years of age.

    - On open skin wounds.

  • WHEN USING

    When using this product - keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin - do not inhale or ingest this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours seek medical attention.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STORAGE AND HANDLING

    - Store between 15-30°C (59-86°F).
    - Avoid freezing and excessive heat above 40°C (104°F).

  • INACTIVE INGREDIENT

    Water, Glycerin

  • DOSAGE & ADMINISTRATION

    Use it as needed, after following the usage instructions. For external use only.

  • PRINCIPAL DISPLAY PANEL

    Biowipes Alcohol Wipes

  • INGREDIENTS AND APPEARANCE
    BIOWIPES ALCOHOL WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81088-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81088-101-01100 in 1 POUCH; Type 0: Not a Combination Product11/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/18/2020
    Labeler - YEMYESIL KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI (533150213)
    Registrant - YEMYESIL KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI (533150213)
    Establishment
    NameAddressID/FEIBusiness Operations
    YEMYESIL KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI533150213manufacture(81088-101)
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