Label: NUMBIFY SANITIZE- benzalkonium chloride 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 April 29, 2020

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

  • WARNINGS

    warnings section

  • PURPOSE

    purpose

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • ACTIVE INGREDIENT

    active ingredients section

  • INDICATIONS & USAGE

    indications and usage

  • INACTIVE INGREDIENT

    inactive ingredients

  • DOSAGE & ADMINISTRATION

    dosage and administration

  • PRINCIPAL DISPLAY PANEL

    principal display panel

  • INGREDIENTS AND APPEARANCE
    NUMBIFY SANITIZE 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS400 mg  in 10000 mg
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 2387 mg  in 10000 mg
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) 100 mg  in 10000 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 6890 mg  in 10000 mg
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 200 mg  in 10000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-089-1428500 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    2NDC:69804-089-1556700 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    3NDC:69804-089-16113400 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/19/2020
    Labeler - Ridge Properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ridge Properties029478762manufacture(69804-089)