MEDROX- methyl salicylate, menthol, capsaicin ointment
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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Medrox (Medroxin)

DRUG FACTS:

ACTIVE INGREDIENTS

Methyl Salicylate 20.00%

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.

KEEP OUT OF REACH OF CHILDREN

Consult physician for children under 12.

DIRECTIONS

Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.

OTHER INGREDIENTS

Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl Myristate, Glycerin, Sodium Lauryl Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5

Medrox

(medroxcin)

Effective
Soothing
Long Lasting

Pain Relief Ointment

For Questions or Comments
Please Email:
info@ipnarx.com

120gm (4 fl oz)

MEDROX
methyl salicylate, menthol, capsaicin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45861-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g in 100 g
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45861-001-60	60 g in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2011	01/01/2018
2	NDC:45861-001-01	120 g in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2011	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/09/2011	01/01/2018

Labeler - Pharmaceutica North America (962739699)

Revised: 2/2019

Document Id: 812b4f4c-4518-f05f-e053-2991aa0a6bd4

Set id: 27a9a7ac-6e1c-4564-bd1b-d6b42edcadaf

Version: 4

Effective Time: 20190205

Pharmaceutica North America