MEDI-DERM RX- methyl salicylate, menthol and capsaicin cream 
Two Hip Consulting, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredients                             

Capsaicin 0.035%
Menthol 5%
Methyl Salicylate 20%

PURPOSE

TOPICAL ANALGESIC

USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

Warnings: For external use only.

DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Water.

OTHER INFORMATION: STORE BELOW 90°F/32°C

QUESTIONS? 888 907-2833

IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN.

Medi-Derm-Rx_151-14

MEDI-DERM  RX
methyl salicylate, menthol and capsaicin cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:76074-151
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL5 g  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN0.035 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
CETOSTEARYL ALCOHOL 
CYPERUS ESCULENTUS LEAF 
GLYCERYL MONOSTEARATE 
FD&C GREEN NO. 3 
HYPROMELLOSE 2208 (100000 MPA.S) 
ISOPROPYL PALMITATE 
METHYLISOTHIAZOLINONE 
PHENOXYETHANOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-151-14120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/18/2012
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 9/2013
Document Id: 35bc35b3-d6ae-4b75-8b7c-4e77c786238a
Set id: 95910cee-0a43-4ac9-aeb9-6a659757b3ba
Version: 6
Effective Time: 20130912
 
Two Hip Consulting, LLC