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Medrox by Preferred Pharmaceuticals, Inc

Medically reviewed on December 20, 2017

Dosage form: ointment
Ingredients: METHYL SALICYLATE 20g in 100g, MENTHOL, UNSPECIFIED FORM 5g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: Preferred Pharmaceuticals, Inc
NDC Code: 68788-9855

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 Analgesi

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

HOW SUPPLIED

60 gram bottle – 68788-9855-6

120 gram bottle – 68788-9855-1

Relabeled By Preferred Pharmaceuticals, Inc

PRINCIPAL DISPLAY PANEL
MEDROX 
methyl salicylate, menthol, capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9855(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, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM5 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:68788-9855-660 g in 1 BOTTLE
2NDC:68788-9855-1120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9855)

 
Preferred Pharmaceuticals, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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