FAMILY CARE THERA FLEX (MENTHOL GLYCOL SALICYLATE NONIVAMIDE TOCOPHEROL ACETATE) PATCH [UNITED EXCHANGE CORP.]

FAMILY CARE THERA FLEX (MENTHOL GLYCOL SALICYLATE NONIVAMIDE TOCOPHEROL ACETATE) PATCH [UNITED EXCHANGE CORP.]
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NDC 65923-012-01
Set ID e9753542-1b08-4dcc-a0f5-299384b44227
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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