GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED (MENTHOL) PATCH [GEISS, DESTIN AND DUNN, INC.]

GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED (MENTHOL) PATCH [GEISS, DESTIN AND DUNN, INC.]
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NDC 50804-126-05
Set ID 7585d111-775f-4fb6-a485-28cd99d88852
Category HUMAN OTC DRUG LABEL
Packager Geiss, Destin and Dunn, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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:

    Geiss, Destin and Dunn, Inc.

    Peachtree City, Ga 30269

    www.valuelabels.com

    1-866-696-0957

    Made in China

  • PRINCIPAL DISPLAY PANEL

    125

  • 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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