Label: EXTRA STRENGTH NATURALLY HL WARMING ICE- 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 February 7, 2017

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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

  • INDICATIONS & USAGE

    indications and usage

  • ACTIVE INGREDIENT

    active ingredientsinactive ingredients

  • INACTIVE INGREDIENT

    inactive ingredients section

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NATURALLY HL WARMING ICE 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-036
    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
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 50 mg  in 1000 mg
    BLACK PEPPER OIL (UNII: U17J84S19Z) 40 mg  in 1000 mg
    GRAPE SEED OIL (UNII: 930MLC8XGG) 120 mg  in 1000 mg
    EUCALYPTUS OIL (UNII: 2R04ONI662) 40 mg  in 1000 mg
    OLIVE OIL (UNII: 6UYK2W1W1E) 120 mg  in 1000 mg
    WHITE WAX (UNII: 7G1J5DA97F) 40 mg  in 1000 mg
    COCOA BUTTER (UNII: 512OYT1CRR) 25 mg  in 1000 mg
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 525 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-036-0614200 mg in 1 JAR; Type 0: Not a Combination Product02/09/2017
    2NDC:69804-036-0528500 mg in 1 JAR; Type 0: Not a Combination Product02/09/2017
    3NDC:69804-036-0256700 mg in 1 JAR; Type 0: Not a Combination Product02/09/2017
    4NDC:69804-036-03113400 mg in 1 JAR; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/09/2017
    Labeler - ridge properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    ridge properties029478762manufacture(69804-036)