Label: ALCOHOL HAND 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 September 6, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Wipes used on hands and skin to reduce bacteria

  • Warnings

    For external use only, do not ingest. Flammable. Keep away from heat, flame, or direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
    • near eyes
  • WHEN USING

    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.

  • Stop Use

    Stop use and ask a doctor if irritation or rash occurs and persists for longer than 72 hours. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Supervise use by children under the age of 6.

  • Directions

    • Peel back open label slowly
    • Pull out one wipe at a time
    • Reseal packaging tightly
    • Wet hands thoroughly with product and allow to dry
    • Supervise children under 6 years of age when using this product to avoid ingestion
  • Storage

    • Avoid freezing and excessive heat above 40C (104F)
    • Store away from direct sunlight
    • Store tightly closed in its original packaging
    • Keep away from food, drinks, and animal feed
    • Store in places unaccessible to children
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Inactive Ingredients

    lemon oil-distilled, peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, water, polysorbate 20, cocamidopropyl betaine, dexpanthenol, glycerin

  • Package Label - Principal Display Panel

    120 Count Canister NDC: 90083-211-12

    200 Count Canister NDC: 90083-211-20

    500 Count Canister NDC: 90083-211-50

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90083-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.059 mL  in 4.37 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90083-211-502185 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
    2NDC:90083-211-20874 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
    3NDC:90083-211-12524.4 mL in 1 CANISTER; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    Labeler - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)
    Registrant - Huzeyfe Islamoglu (595865355)
    Establishment
    NameAddressID/FEIBusiness Operations
    OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI595865355manufacture(90083-211)
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