Label: GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED- 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 June 30, 2013

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                Purpose

    Menthol 5%..........................................................Topical analgesic

  • PURPOSE

    Uses temporarily relieves minor pain associated with:

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

    Warnings For External Use Only

  • WHEN USING

    When using this product:

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

    Stop use and ask a doctor if:

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions

    • adults and children over 12 years:
    • carefully remove backing from patch
    • apply sticky side of patch to affected area
    • should be used up to 8 hours
    • should be used no more than 3 times a day
    • children 12 years or younger: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature, not to exceed 86°F (30°C)
    • Reports of serious side effects associated with the use of this product can be sent to:
    • 17211 Valley View Ave. Cerritos, CA 90703
  • INACTIVE INGREDIENT

    Inactive ingredients: Aloe Vera, Aluminum Hydroxide, Disodium Edate, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Polysorbate 80, Tocopherol Acetate, Magnesium Aluminometasilicate, Castor Oil, Tartaric Acid, Polyethylene Glycol Monostearate, BHT, Sodium POlyacrylate. Release liner: Polypropylene, Non-woven material: Polyester non-woven fabric

  • DOSAGE & ADMINISTRATION

    Distributed by: Geiss, Destin and Dunn, Inc.

    Peachtree City, GA 30269

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    TARTARIC ACID (UNII: W4888I119H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-124-055 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - Geiss, Destin and Dunn, Inc. (076059836)