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Medrox

Dosage form: ointment
Ingredients: METHYL SALICYLATE 20g in 100g, MENTHOL 5g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: Lake Erie Medical DBA Quality Care Products LLC
NDC Code: 35356-831

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.

Medrox (Medroxin)

DRUG FACTS:

ACTIVE INGREDIENTS

Methyl Salicylate      20.00%

Menthol                     5.00%

Capsaicin                  0.0375%

PURPOSE

Analgesic/Counterirritant

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

Image of Label

MEDROX 
methyl salicylate, menthol, capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35356-831(NDC:45861-001)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 g  in 100 g
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
PEG-150 DISTEARATE 
ISOPROPYL MYRISTATE 
GLYCERIN 
SODIUM LAURYL SULFATE 
POLYSORBATE 20 
TROLAMINE 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
DIAZOLIDINYL UREA 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:35356-831-01120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/09/2011
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Lake Erie Medical DBA Quality Care Products LLC831276758relabel(35356-831)

Revised: 06/2013
 
Lake Erie Medical DBA Quality Care Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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