Label: HAND WIPES TOWELETTES- 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 ingredient

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    • In children less than 2 months of age
    • On open skin wounds
  • When using this product

    keep out of eyes, ears, and mouth. Incase 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.

    Keep out of reach of children. If swalled, get medical help or contact a PoisonControl Center right away.

  • Directions

    • Wipe hands;discard
  • Other Instructions

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive Ingredients

    Water, Fragrance

  • SPL UNCLASSIFIED SECTION

    FIVESTAR (TM)

    HAND SANI-WIPE

    HAND SANITIZER 80& ALCOHOL CONTENT

    KILLS 99.9% OF GERMS

    ITEM: 91205

    Product of Turkey

    Distributed by: Schreiber Foods International, Inc. Ramsey NJ 07466

    FiveStarPPE.com or call 1-800-631-7070

  • Label - Antiseptic Towlette

    Label - Antiseptic Towlette.jpg

  • INGREDIENTS AND APPEARANCE
    HAND WIPES  TOWELETTES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76758-912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76758-912-101000 in 1 CARTON07/27/2020
    12.5 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 finalpart333A07/27/2020
    Labeler - Schreiber Foods International, Inc. (037138096)
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