Label: CONSULT HEALTH PERSISTENCE HAND SANITIZER- benzalkonium chloride liquid

  • 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 July 23, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial and First aid antiseptic

  • Uses:

    • For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. • For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

  • Warnings:

    For external use only.

    When using this product

    avoid contact with eyes. In case of eye contact, flush eyes with water.

    Discontinue use if

    irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Spray onto hands as needed. Pump onto hands as needed. Rub briskly together until dry. No rinsing required. • Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

  • Inactive ingredients

    ionized water, carbamide

  • ​Questions or Comments?

    1-866-272-4425

  • Package Labeling:

    LabelLabel2

  • Package Labeling: 97.59mL

    Label3

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    CONSULT HEALTH PERSISTENCE HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70803-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70803-004-09264 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    2NDC:70803-004-0397.59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    3NDC:70803-004-0259.15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Geo Management Corporation (102875148)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cemi International, Inc015038336manufacture(70803-004)
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