Label: FAMILY WELLNESS COLD AND HOT PAIN RELIEF- menthol patch

  • Category: HUMAN OTC DRUG LABEL

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 November 30, 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
    • 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
    • repeat as necessary, but no more than 4 times daily
    children 12 years of younger:
    • ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

    Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    FAMILY DOLLAR SERVICES, INC.

    10401 MONROE RD.,

    MATTHEWS, NC 28105 USA

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-026
    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:55319-026-031 in 1 CARTON
    13 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/30/2012
    Labeler - FAMILY DOLLAR (024472631)
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