MEDROX- menthol, capsaicin, methyl salicylate patch

Medrox by

Drug Labeling and Warnings

Medrox by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc., SMARTDATA SUZHOU CO., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

methyl salicylate 5% analgesic/counterirritant

menthol 5% analgesic/counterirritant

capsaicin 0.0375% external analgesic

INACTIVE INGREDIENT

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

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

PURPOSE

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

WARNINGS

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.

STORAGE AND HANDLING

store below 25 degrees, avoid direct sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDROX 
menthol, capsaicin, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.0375 g  in 100 g
methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	methyl salicylate	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-009-06	10 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/27/2011

Labeler - Pharmaceutica North America, Inc. (962739699)

Registrant - SMARTDATA SUZHOU CO., Ltd (529507479)