Label: FAMILY CARE THERA FLEX- menthol glycol salicylate nonivamide tocopherol acetate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-012-01 - Packager: United Exchange Corp.
- 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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- Official Label (Printer Friendly)
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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
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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
- ASK DOCTOR
- WHEN USING
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE THERA FLEX
menthol glycol salicylate nonivamide tocopherol acetate patchProduct 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)