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 Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5694
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5694-01 1 in 1 PACKAGE
1 5 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/30/2013
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