Label: PROBALANCE HAND SANITIZER ADVANCED- alcohol gel

  • 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 May 20, 2020

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  • SPL UNCLASSIFIED SECTION

    PROBALANCE Hand Sanitizer Advanced Gel

    Drug Facts

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from source of heat, fire or flame.

    For external use only. Not for Consumption.

  • When using this product

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops and lasts.

  • 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.

  • Directions

    Directions

    • place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
    • children under 6 years should be supervised when using this product.
  • Inactive ingredients

    Water, hydroxypropyl guar, citric acid

  • Active ingredient

    Alcohol 70% v/v

  • Other information

    Other information

    • store at a temperature below 110 F (43 C).
    • may discolor certain fabrics or surfaces.
  • Package Label - Principal Display Panel

    Label

    78072-501-10 - 1 gallon

    One Gallon Label

  • INGREDIENTS AND APPEARANCE
    PROBALANCE HAND SANITIZER ADVANCED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78072-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78072-501-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    2NDC:78072-501-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2020
    Labeler - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)
    Registrant - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)
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