MAJOR EXTRA STRENGTH COLD AND HOT PAIN RELIEF THERAPY - menthol patch 
Major Pharmaceuticals

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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Drug Facts

Active ingredient                                                                                Purpose

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

Uses Temporarily relieves minor pain associated with:

Warnings For external use only

When using this product

Stop use and ask a doctor if

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

Other information

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
Document Id: 7d87e7c1-dd7e-4ad7-b734-4c180cb1811b
Set id: 33e3bc1d-3eb7-4f04-9002-6a384c91fc3d
Version: 1
Effective Time: 20130630
 
Major Pharmaceuticals