Your browser does not support JavaScript! MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (MENTHOL) PATCH [MAJOR PHARMACEUTICALS]
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MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY (menthol) patch
[Major Pharmaceuticals]


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 Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • 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

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

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

Directions

  • adults and children 12 years of age and older
  • carefully peel off protective backing from patch and apply sticky side to affected area
  • may be worn up to 8 hours
  • do not use 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 1,3-butlene glycol, aloe vera (powder), metacrylic acid butlacrylate copolymer, dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminium hydrate, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

Distributed By:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150

Made in Korea

image of carton label

MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY 
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-5694
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ALOE VERA LEAF 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
KAOLIN 
LIGHT MINERAL OIL 
METHYLPARABEN 
POLYSORBATE 80 
WATER 
SODIUM POLYMETAPHOSPHATE 
SORBITAN MONOOLEATE 
TARTARIC ACID 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5694-011 in 1 PACKAGE
15 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2013
 
Major Pharmaceuticals

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