Your browser does not support JavaScript! EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]
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EXTRA STRENGTH PAIN RELIEF THERAPY (menthol) patch
[United Exchange Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredient                                                                       Purpose

Menthol 5%.................................................................Topical analgesic

Uses Temporary relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • bruises
  • cramps

Warnings For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • adults and children 12 years of age and older:
  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children under 12 years of age:
  • consult a doctor

Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive ingredients aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non woven fabric.

Distributed by:

United Exchange Corp

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image of carton label
EXTRA STRENGTH PAIN RELIEF THERAPY  
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65923-701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
BUTYLATED HYDROXYTOLUENE 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
TARTARIC ACID 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-701-055 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - United Exchange Corp (840130579)

Revised: 6/2013
 
United Exchange Corp

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