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

If you are a consumer or patient please visit this version.

  • 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

    Close
  • PURPOSE

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

    • strains
    • sprains
    • simple backache
    • arthritis
    • bruises
    Close
  • 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
    Close
  • 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

    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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.

    Close
  • 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.

    Close
  • 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
    Close
  • 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)
    Close
  • 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

    Close
  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

    Close
  • INGREDIENTS AND APPEARANCE
    FAMILY CARE THERA FLEX 
    menthol glycol salicylate nonivamide tocopherol acetate patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-012
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6.53 mg  in 100 mg
    GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE 4.66 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 Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-012-01 1 in 1 POUCH
    1 1 mg in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/15/2013
    Labeler - United Exchange Corp. (840130579)
    Close