MEDI-SULTING TOPICAL PAIN RELIEF - methyl salicylate, menthol, capsaicin and lidocaine cream 
Two Hip Consulting, LLC

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.

----------

CAPSAICIN 0.035%

LIDOCAINE 2%

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.

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-Sulting Two Hip Consulting-Medi-Derm-L Label Final

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.


MEDI-SULTING TOPICAL PAIN RELIEF 
methyl salicylate menthol capsaicin lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76074-122
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) CAPSAICIN.0355 g  in 100 mL
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
CETOSTEARYL ALCOHOL 
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 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76074-122-14120 mL in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/18/2012

Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 09/2012 Two Hip Consulting, LLC