FDA Label for Family Care Thera Flex

Otc - 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

Otc - 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

Otc - 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

Otc - 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

Otc - 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

Otc - 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

Otc - 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.

Otc - 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