Label: GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch

  • NDC Code(s): 50804-126-05
  • Packager: Geiss, Destin and Dunn, Inc.
  • 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 May 26, 2022

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  • ACTIVE INGREDIENT

    Active ingredient                                                 Purpose

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

  • PURPOSE

    Uses

    temporariliy relieves minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • burises
    • sprains
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wonunds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you have

    • redness over the affected area
  • WHEN USING

    When using this product:

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • open pouch and remove patch
    • carefully peel off protective backing and apply sticky side to affected area
    • adults and children 12 years of age or older
    • do not wear patch for more than 8 hours
    • apply to affected area no more than 3 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Perrigo Direct, Inc.

    Peachtree City, Ga 30269

    www.PerrigoDirect.com

    1-866-696-0957

    Made in China

  • PRINCIPAL DISPLAY PANEL

    125A.1

  • INGREDIENTS AND APPEARANCE
    GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-126-051 in 1 CARTON12/26/2018
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/26/2018
    Labeler - Geiss, Destin and Dunn, Inc. (076059836)
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