Label: FAMILY CARE THERA FLEX- menthol glycol salicylate nonivamide tocopherol acetate 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 15, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients (in each patch)                                                                     Purpose

    Menthol 6.53%........................................................................................... Topical analgesic

    Glycol Salicylate 4.66%............................................................................... Topical analgesic

    Nonivamide 0.01%...................................................................................... Topical analgesic

    Tocopherol Acetate 0.93%............................................................................ Topical analgesic

  • PURPOSE

    Uses: Temporarily relieves mild to moderate aches & pain of muscles & joints associated with:

    • strains
    • sprains
    • simple backache
    • arthritis
    • bruises
  • WARNINGS

    For external use only

    Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:

    • are 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using the product
    • take more or for a longer time than directed
  • DO NOT USE

    Do not use:

    • on the face or rashes
    • on wounds or damaged skin
    • if allergic to aspirin or other NSAIDs
    • with a heating pad
    • when sweating (such as from exercise or heat)
    • any patch from a pouch that has been open for 14 or more days
    • right before or after heart surgery

  • ASK DOCTOR

    Ask a doctor before use:

    • if you are allergic to topical products
    • the stomach bleeding warning applies to your
    • you have high blood pressure, heart disease, or kidney disease
    • you are taking a diuretic
  • WHEN USING

    When using this prdouct

    • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occures, rinse thoroughly with water
    • the risk of hear attack or stroke may increase if you use more than directed or for longer than directed
  • STOP USE

    Stop use and ask a doctor if:

    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
    • rash, itching or skin irritation develops
    • conditions worsens
    • symptoms last for more than 3 days
    • symptoms clear up and occur again within a few days
    • stomach pain or upset gets worse or lasts
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a doctor before use while breast-feeding or during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complcations during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    If put in mouth, get medical help or contact a Poision Contol Center right away. Package not child resistant.

  • INDICATIONS & USAGE

    Directions: Adult 18 years and older

    • clean and dry affected area
    • remove patch from backing film and apply to skin (see illustration)
    • apply one patch to the affected area and leave in place for up to 8 to 12 hours
    • if pains last after using the first patch, a second patch may be applied for up to another 8 to 12 hours
    • only use on patch at a time
    • do not use more than 2 patches per day
    • do not use for more than 3 days in a row
    • Children under 18 years of age: do not use
  • STORAGE AND HANDLING

    Other Information

    • some individuals may not experience pain relief until several hours after applying the patch
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
    • store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients: aliphatic hydrocarbon resin, castor oil, dibutyl hydroxy toluene, glycerine, isopropyl myristate, metacrylic acid butylacrylate copolymer, natural rubber latex, polysorbate 60, sorbitan monostearate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE THERA FLEX 
    menthol glycol salicylate nonivamide tocopherol acetate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.53 mg  in 100 mg
    GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE4.66 mg  in 100 mg
    NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR) NONIVAMIDE.01 mg  in 100 mg
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE.93 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-012-011 in 1 POUCH
    11 mg in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/2013
    Labeler - United Exchange Corp. (840130579)