Label: INSTANT HAND SANITIZER GEL- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 12, 2013

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  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • To help decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    • Keep out of eyes. In case of eye contact, flush it thoroughly with water, seek medical attention immediately.
    • Avoid contact with broken skin.

    • Stop use and ask a doctor if redness or Irritation develops and persists for more than 72hrs.

    • Keep away from children. If swallowed, seek medical attention immediately. Children must only use this product under adult supervision.
  • Direction

    • Place small amount of Bonita sanitizer in your palm. Thoroughly spread on both hands and rub together until dry.
  • Other Information

    • Store below 105 ˚F.
    • May discolor some fabrics.
  • Inactive Ingredients

    • Water
    • Propylene glycol
    • Isopropyl alcohol
    • PEG-12
    • Carbomer 940
    • Fragrance
    • Triethanolamine
  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer Gel Label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18.6 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53598-007-0130 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/12/2013
    Labeler - Bonita Pharmaceuticals LLC (004219442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bonita Pharmaceuticals LLC004219442label(53598-007)
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