Label: DG HEALTH EXTRA STRENGTH 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 December 31, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                             Purpose

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


  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • 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 a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin, broken or irritated skin
  • STOP USE

    Stop use and ask a doctor if

    • conditions worsens
    • redness is present
    • irritation develops
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin, broken or irritated skin
  • 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 right away.

  • INDICATIONS & USAGE

    Directions adults and children over 12 years

    • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • apply one patch to affected area
    • repeat as necessary, but no more than 3 times daily
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature, not to exceed 86°F (30°C)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminate metasilicate, methyl paraben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    DOLGEN CORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    DG HEALTH EXTRA STRENGTH MEDICATED  
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-391
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-391-011 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/31/2012
    Labeler - DOLGENCORP INC (068331990)
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