Label: THANN SIGNATURE HAND SANITISING WIPE- 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 October 29, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antibacterial

  • Uses

    - To help reduce bacteria on the skin.

  • Warnings

    -For external use only.
    Flammable. Keep away from fire or flame.

    When using this product

    -Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop using and ask a doctor if

    -Irritation and redness. Develops and lasts.

    Keep out of reach of children

    -In case of accidental ingestion, get medical help or contact a poison control center immediately.

  • Directions

    -Apply to palm/ skin.

    No rinsing required. Discard after use.

  • Other information

    -Store in room temperature.

  • Inactive Ingredients

    -Aqua (Water), Glycerin, Polysorbate 20, Parfum (Fragrance), Polyquaternium-37, Oryza Sativa (Rice) Bran Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.

  • Package Labeling:

    Bottle5

  • INGREDIENTS AND APPEARANCE
    THANN SIGNATURE HAND SANITISING WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79940-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79940-003-011 in 1 BAG10/31/2020
    15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/31/2020
    Labeler - FORMIA Airline Supplies Ltd (668098317)
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