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

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EXTRA STRENGTH PRETAT (LIDOCAINE HCL) GEL [RIDGE PROPERTIES]
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NDC 69804-019-14, 69804-019-15, 69804-019-16
Set ID 39be90c4-b32c-2041-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 administration

  • INACTIVE INGREDIENT

    inactive ingredients

  • INDICATIONS & USAGE

    indications and usage

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • ACTIVE INGREDIENT

    active ingredient

  • PURPOSE

    purpose

  • WARNINGS

    warnings

  • PRINCIPAL DISPLAY PANEL

    principal display panel

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PRETAT 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-019
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 20 mg  in 1000 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 689 mg  in 1000 mg
    BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg  in 1000 mg
    COPAIBA OIL (UNII: 64VX45Y68N) 180 mg  in 1000 mg
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) 11 mg  in 1000 mg
    WATER (UNII: 059QF0KO0R) 50 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-019-1428350 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/17/2016
    2NDC:69804-019-1556699 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/17/2016
    3NDC:69804-019-16113398 mg in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/17/2016
    Labeler - ridge properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ridge Properties029478762manufacture(69804-019)
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