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 |
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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
-
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)