MEDROX- menthol, capsaicin patch

MEDROX by

Drug Labeling and Warnings

MEDROX by is a Otc medication manufactured, distributed, or labeled by Unit Dose Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (MENTHOL, CAPSAICIN ) PATCH

INGREDIENTS AND APPEARANCE

MEDROX  
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50436-9991(NDC: 45861-014)
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	0.0375 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50436-9991-1	5 g in 1 BOX

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

Labeler - Unit Dose Services (831995316)

Registrant - Unit Dose Services (831995316)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Services		831995316	REPACK(50436-9991)