FAMILY CARE THERA FLEX- menthol glycol salicylate nonivamide tocopherol acetate patch 
United Exchange Corp.

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.

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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

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

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:

Do not use:

Ask a doctor before use:

When using this prdouct

Stop use and ask a doctor if:

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.

If put in mouth, get medical help or contact a Poision Contol Center right away. Package not child resistant.

Directions: Adult 18 years and older

Other Information

Inactive ingredients: aliphatic hydrocarbon resin, castor oil, dibutyl hydroxy toluene, glycerine, isopropyl myristate, metacrylic acid butylacrylate copolymer, natural rubber latex, polysorbate 60, sorbitan monostearate

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

image description

FAMILY CARE THERA FLEX 
menthol glycol salicylate nonivamide tocopherol acetate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.53 mg  in 100 mg
GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE4.66 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-012-011 in 1 POUCH
11 mg in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/2013
Labeler - United Exchange Corp. (840130579)

Revised: 11/2013
Document Id: b9b4142f-f721-4e0b-b02b-156a9fdc96a9
Set id: e9753542-1b08-4dcc-a0f5-299384b44227
Version: 7
Effective Time: 20131115
 
United Exchange Corp.