FAMILY CARE THERA FLEX- menthol glycol salicylate nonivamide tocopherol acetate patch

Family Care Thera Flex by

Drug Labeling and Warnings

Family Care Thera Flex by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)