Label: NATURALLY HL EXTRA STRENGTH BURN NUMBING- lidocaine hcl cream

  • 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 March 23, 2016

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  • DOSAGE & ADMINISTRATION

    dosage and administration

  • WARNINGS

    keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    warning

  • PURPOSE

    purpose

  • INDICATIONS & USAGE

    uses

  • ACTIVE INGREDIENT

    active ingredients

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    principal display panel

  • INGREDIENTS AND APPEARANCE
    NATURALLY HL EXTRA STRENGTH BURN NUMBING 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-010
    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
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 120 mg  in 1000 mg
    PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 190 mg  in 1000 mg
    ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 60 mg  in 1000 mg
    COPAIBA OIL (UNII: 64VX45Y68N) 90 mg  in 1000 mg
    NUTMEG OIL (UNII: Z1CLM48948) 60 mg  in 1000 mg
    WITCH HAZEL (UNII: 101I4J0U34) 440 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-010-0256700 mg in 1 JAR; Type 0: Not a Combination Product04/06/2016
    2NDC:69804-010-03113400 mg in 1 JAR; Type 0: Not a Combination Product04/06/2016
    3NDC:69804-010-0528500 mg in 1 JAR; Type 0: Not a Combination Product04/06/2016
    4NDC:69804-010-0614200 mg in 1 JAR; Type 0: Not a Combination Product04/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2016
    Labeler - Ridge Properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ridge properties029478762manufacture(69804-010)