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.

----------

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

children 12 years or younger:

Other information

Inactive ingredients 1,3-butlene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Distributed By:

Major Pharmaceuticals

17177 N Laurel Park Dr.

Suite 233

Livonia, MI 48150

Made in Korea

image description

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
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)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MAGALDRATE (UNII: 6V88E24N5T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
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 02/03/2017
1 5 in 1 POUCH; Type 0: Not a Combination Product
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: 2/2017
Document Id: 4dd34a21-da49-4c56-8fd2-66183e615a29
Set id: 33e3bc1d-3eb7-4f04-9002-6a384c91fc3d
Version: 2
Effective Time: 20170203
 
Major Pharmaceuticals