EXTRA STRENGTH NUMBING GEL (LIDOCAINE HCL) GEL [RIDGE PROPERTIES]

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EXTRA STRENGTH NUMBING GEL (LIDOCAINE HCL) GEL [RIDGE PROPERTIES]
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NDC 69804-021-09, 69804-021-10, 69804-021-11, 69804-021-12
Set ID 45ae0ceb-a13c-362f-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Ridge Properties
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • DOSAGE & ADMINISTRATION

    dosage and asministration

  • WARNINGS

    warnings section

  • KEEP OUT OF REACH OF CHILDREN

    otc keep out of reach of children

  • PURPOSE

    otc purpose section

  • INDICATIONS & USAGE

    indications and usage

  • ACTIVE INGREDIENT

    ot5c active ingredient section

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NUMBING GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WITCH HAZEL (UNII: 101I4J0U34) 315 mg  in 1000 mg
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 5 mg  in 1000 mg
    AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE) 110 mg  in 1000 mg
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN) 5 mg  in 1000 mg
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 525 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-021-0914200 mg in 1 JAR; Type 0: Not a Combination Product01/13/2017
    2NDC:69804-021-1028500 mg in 1 JAR; Type 0: Not a Combination Product01/13/2017
    3NDC:69804-021-1156700 mg in 1 JAR; Type 0: Not a Combination Product01/13/2017
    4NDC:69804-021-12113400 mg in 1 JAR; Type 0: Not a Combination Product01/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/13/2017
    Labeler - Ridge Properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ridge Properties029478762manufacture(69804-021)
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