Label: RICORA- lidocaine hydrochloride, menthol patch

  • 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 December 1, 2015

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  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Lidocaine HCL 4.00%
    Menthol 1.00%

    Topical Anesthetic

    External Analgesic

  • USES:

    For temporary relief of pain associated with minor: •cuts •scrapes •skin irritations

  • WARNINGS:

    • For external use only.
    • Avoid contact with eyes.
    • Do not apply on open wounds or damaged skin.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    • Keep out of reach of children.

    If swallowed, consult physician.

    • Do not bandage tightly.

    If pregnant or breastfeeding,

    contact physician prior to use.

    Do not

    use in large quantities, particularly over raw surfaces or blistered areas.

  • DIRECTIONS:

    (Adults and Children 12 years of age and over)

    • Clean and dry affected area.

    • Remove patch from backing and apply to affected area.

    • Use only one patch at a time, and maximum of four patches/day.

    • Leave patch on affected area for up to 8 hours.

    • Do not use patches for longer than 5 consecutive days.

    • Children under 12 should consult physician prior to use.

  • INACTIVE INGREDIENTS:

    Glyceryl Hydrogenated Rosinate, Hydrated  Silica, Mineral Oil, PEG-400, Polyisobutene, Styrene/Isoprene Copolymer

  • SPL UNCLASSIFIED SECTION

    Creates a warming sensation to the applied area.

    Store below 25 degrees. Avoid direct sunlight.

  • Package Lebeling:

    Imagelabel1

  • INGREDIENTS AND APPEARANCE
    RICORA 
    lidocaine hydrochloride, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69418-006-306 in 1 BOX
    15 in 1 POUCH
    12.3 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/21/2015
    Labeler - Meds Direct Rx, Inc. (064053428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meds Direct Rx, Inc.064053428repack(69418-006) , relabel(69418-006)
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