Label: TOPCARE MEDICATED  - menthol patch 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

    Menthol 5%........................................................Topical Analgesic

    Close
  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
    Close
  • WARNINGS

    Warnings

    • For external use only
    Close
  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
    Close
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

    Close
  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older
    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • apply one patch to affected area
    • repeat as necessary, but no more than 4 times daily
    • children under 12 years of age: consult a doctor
    Close
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    Close
  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, caster oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, tocopherol acetate, sodium polyacrylate, tartaric acid, tianium dioxide. Release Liner: polypropylene. Non-Woven Material: polyester non-woven fabric.

    Close
  • DOSAGE & ADMINISTRATION

    Distributed By:

    TOPCO Associates LLC

    150 Northwest Point Boulevard

    Elk Grove Village, IL 60007

    Made in Korea

    Close
  • INGREDIENTS AND APPEARANCE
    TOPCARE MEDICATED  
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-152
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALUMINUM HYDROXIDE  
    BUTYLATED HYDROXYTOLUENE  
    EDETATE DISODIUM  
    GELATIN  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    KAOLIN  
    METHYLPARABEN  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    WATER  
    ALPHA-TOCOPHEROL ACETATE  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-152-05 1 in 1 CARTON
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/30/2013
    Labeler - Top Care (006935977)
    Close