Label: KAC ZAPX HAND SANITIZER- ethyl alcohol hand sanitizer 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 June 10, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 72% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • 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

    When using this product keep out of eyes, ears, and mouth. In case 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

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

    Glycerin, Propylene Glycol, Monoethanolamine, purified water USP

  • PRINCIPAL DISPLAY PANEL

    2oz

  • INGREDIENTS AND APPEARANCE
    KAC ZAPX HAND SANITIZER 
    ethyl alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78919-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MONOETHANOLAMINE (UNII: 5KV86114PT) 1 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78919-102-0259.14 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    2NDC:78919-102-0388.72 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    3NDC:78919-102-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    4NDC:78919-102-32946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    5NDC:78919-102-641892.71 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2020
    Labeler - Klein Anderson Corp (805627382)
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