EXTRA STRENGTH SUNBURN RELIEF (LIDOCAINE HCL) CREAM [RIDGE PROPERTIES]

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EXTRA STRENGTH SUNBURN RELIEF (LIDOCAINE HCL) CREAM [RIDGE PROPERTIES]
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NDC 69804-039-02, 69804-039-03, 69804-039-05, 69804-039-06
Set ID 4820e1ed-e9b9-0ad7-e054-00144ff88e88
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

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    purpose section

  • INDICATIONS & USAGE

    indications and usage

  • ACTIVE INGREDIENT

    active ingredients

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SUNBURN RELIEF 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-039
    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
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) 40 mg  in 1000 mg
    PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 190 mg  in 1000 mg
    WITCH HAZEL (UNII: 101I4J0U34) 400 mg  in 1000 mg
    COPAIBA OIL (UNII: 64VX45Y68N) 90 mg  in 1000 mg
    NUTMEG OIL (UNII: Z1CLM48948) 60 mg  in 1000 mg
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 120 mg  in 1000 mg
    ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 60 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-039-0614200 mg in 1 JAR; Type 0: Not a Combination Product02/10/2017
    2NDC:69804-039-0528500 mg in 1 JAR; Type 0: Not a Combination Product02/10/2017
    3NDC:69804-039-0256700 mg in 1 JAR; Type 0: Not a Combination Product02/10/2017
    4NDC:69804-039-03113400 mg in 1 JAR; Type 0: Not a Combination Product02/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2017
    Labeler - ridge properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    ridge properties029478762manufacture(69804-039)
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