Label: SOLMARA- menthol, unspecified form and lidocaine 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 July 21, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Menthol 5.00%Topical Analgesic
    Lidocaine 4.00%Topical Anesthetic
  • Uses

    For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

  • Warnings

    Only for external use. Use only as directed or by a health professional.

    Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

    Do not cover with bandage.

    Keep out of the reach of children. Consult physician for children under 12.

    Consult your physician: if pregnant or pain persists or worsens.

  • Directions

    Adults and children 12 years and over. Apply patch to affected area 1 to 2 times daily or as directed.

    Instruction for Use

    Clean and dry the affected area

    Open pouch and remove one patch

    Remove any protective film and apply directly to affected area of pain

    Wash hands with soap and water after applying patch

    Reseal pouch containing unused patches after each use

  • Other Ingredients

    Methacrylic acid, ethylhexylacrylate, bentonite, sodium stearate.

  • QUESTIONS

    FOR QUESTIONS CALL 813-388-8735

  • PRINCIPAL DISPLAY PANEL - 15 Patch Carton

    NDC 69833-011-15

    Solmara
    Lidocaine 4%,Menthol 5%

    15
    Patches

    Principal Display Panel - 15 Patch Carton
  • INGREDIENTS AND APPEARANCE
    SOLMARA 
    menthol, unspecified form and lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69833-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form5 g
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine4 g
    Inactive Ingredients
    Ingredient NameStrength
    2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)  
    Methacrylic Acid (UNII: 1CS02G8656)  
    Bentonite (UNII: A3N5ZCN45C)  
    Sodium Stearate (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69833-011-155 in 1 CARTON
    13 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34807/20/2015
    Labeler - Spring Hill Therapeutics LLC (079813250)
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