MEDROX - menthol and capsaicin patch
Pharmaceutica North America

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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ACTIVE INGREDIENTS

Menthol 5.00%

Capsaicin 0.0375%

PURPOSE

Analgesic/Counterirritant

External Analgesic

USES

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.
Consult physician for children under 12.
Do not use if you are allergic to 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
Or rash, itching or excessive skin irritation occurs.

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

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 area not more than 3 times daily
Wash hands with soap after applying patch
Reseal pouch containing unused patches

OTHER INGREDIENTS

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

MEDROX Patch 5 Patches (45861-014-05)

MEDROX
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45861-014
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	5 g in 100 g
CAPSAICIN (CAPSAICIN)	CAPSAICIN	0.0375 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
GLYCERIN
POLYSORBATE 80
ALOE VERA LEAF
EDETATE DISODIUM
DIAZOLIDINYL UREA
METHYLPARABEN
IODOPROPYNYL BUTYLCARBAMATE
PROPYLPARABEN

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:45861-014-05	5 PATCH ( PATCH) in 1 BOX	contains a PATCH
1		10 g in 1 PATCH	This package is contained within the BOX (45861-014-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/13/2012

Labeler - Pharmaceutica North America (962739699)

Establishment
Name	Address	ID/FEI	Operations
Pure Source, Inc.		969241041	manufacture

Revised: 06/2012 Pharmaceutica North America