MEDROX- menthol, capsaicin, methyl salicylate patch 
Pharmaceutica North America, Inc.

----------

Medrox Patch 5%

methyl salicylate 5% analgesic/counterirritant

menthol 5% analgesic/counterirritant

capsaicin 0.0375% external analgesic

water, glycerine, sodium polyacrylate, polysorbate 80, alo barbadesis leaf (aloe vera gel) juice, EDTA disodium salt, diazolidinyl urea, methylparaben, idopropynl butylcabamate, propylparaben.

Keep out of reach of children. consult physician for children under 12.

adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.

children under 12 years, consult physician before use.

How to apply:

    clean and dry affected area

    cut open pouch and remove patch

    remove protective film and apply directly to area of pain

    apply to affected are not move than 3 times daily

    wash hands with soap after applying patch

    reseal pouch containing unused patches

use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

for external use only. use only as directed. avoid contact with eyes and mucous membranes.

do not cover with bandage.

do not use on wounds or damaged skin.

keep out of reach of children. consult physician for children under 12.

do not use if you are allergic to methyl salicylate or menthol.

stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.

if rash, itching or excessive skin irritations occurs.

store below 25 degrees, avoid direct sunlight.

image

MEDROX 
menthol, capsaicin, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DISODIUM SULFOSALICYLATE (UNII: WFP6MAA96R)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45861-009-0610 g in 1 PACKET; Type 0: Not a Combination Product10/27/201112/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/27/201112/01/2024
Labeler - Pharmaceutica North America, Inc. (962739699)
Registrant - SMARTDATA SUZHOU CO., Ltd (529507479)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(45861-009)

Revised: 12/2024
 
Pharmaceutica North America, Inc.