Label: INSTANT HAND SANITIZER GEL- alcohol gel 

  • Label RSS
  • NDC Code(s): 53598-007-01
  • Packager: Bonita Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

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  • Purpose

    Antiseptic

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  • Uses

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

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

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

    • Water
    • Propylene glycol
    • Isopropyl alcohol
    • PEG-12
    • Carbomer 940
    • Fragrance
    • Triethanolamine
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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53598-007
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 18.6 mL  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    ISOPROPYL ALCOHOL  
    POLYETHYLENE GLYCOL 600  
    CARBOMER 940  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53598-007-01 30 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/12/2013
    Labeler - Bonita Pharmaceuticals LLC (004219442)
    Establishment
    Name Address ID/FEI Business Operations
    Bonita Pharmaceuticals LLC 004219442 label(53598-007)
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